CN106457394A - DMLS orthopedic intramedullary device and method of manufacture - Google Patents

Abstract

An orthopedic device, such as an intramedullary nail, for internal fixation of a bone and a method of manufacturing the same. The orthopedic device may be formed from a medical grade powder via an additive manufacturing process. The forming process may include heat treating the additive manufactured component and machining the heat treated additive manufactured component to form the orthopedic device. Further, the orthopedic device may be formed to include an internal sensor probe channel that extends within at least a portion of the wall of the device, but which does not protrude through an outer portion of the wall. Embodiments further include a dynamizing intramedullary nail that accommodates adjustments in the relative axial positions of one or more sections of the orthopedic device. The device may include features in an inner region of the orthopedic device that may alter an elastic modulus of the orthopedic device.

Description

The orthopedic intramedullary devices of DMLS and manufacture method

Cross-Reference to Related Applications

This application claims in the U.S. Provisional Patent Application sequence number 61/978,804 of on April 11st, 2014 submission with 2014 4 The rights and interests of the U.S. Provisional Patent Application sequence number 61/978,806 that the moon 11 was submitted to, the two is integrally incorporated into herein by quoting In.

Technical field

The present invention generally relates to the implant in orthopaedic surgery or operation, and more specific but non-exclusive Ground, is related to the fixing orthopedic intramedullary devices in the inside for bone of for example orthopedic intramedullary nail etc, and the side manufacturing this device Method.

Background technology

Orthopedic fixator can be used for for example stable damage, supports fracture, merges joint and/or correction deformity.Outside shaping Section's fixing device can permanently or temporarily be attached, and can be attached to bone at various positions, including the pipe of implantation bone Or in other chambeies, be implanted in below soft tissue and be attached to the outer surface of bone, or it is arranged on outside and passes through such as screw, pin And/or the securing member attachment of line etc.Some orthopedic fixators allow two or more bone pieces or two or more bones Position and/or orientation be adjustable relative to each other.Orthopedic fixator is generally processed by isotropic material or is molded, example As included the metal of such as titanium, titanium alloy, stainless steel, cochrome and tantalum.

Additionally, in marrow（IM）The major function of nail is stable fracture fragment, and so that can cross over fracture site Carry out load transmission, keep the anatomical alignment of bone simultaneously.Although commercially there are commercially available intramedullary nails different in a large number, There is no general guide, the condition that every kind of nail will be executed with its optimum performance in a given case is described.Additionally, optimal implant Rigidity degree is the topic of some arguements, and the machine of the interaction substantially between local mechanical environment and union System is typically unknown.

Additionally, reverse and bending in terms of, the impact to union of the rigidity of fixation of change can provide to fracture and The seeing clearly of non-united pathogenesis and ideal treatment.However, at least due to cost control reason, similar implant is used for Simple and complicated both fracture.Therefore, closer to bone rather than titanium or stainless axial bending and torsional rigidity in terms of Find the union that best solution relatively may accelerate certain types of fracture.

Remain a need for the improved orthopedic intramedullary devices fixing for the inside of bone and its manufacture method.The present invention is full This needs of foot, and provide other benefits and advantage in novel and non-obvious mode.

Content of the invention

One aspect of the present invention is a kind of method for manufacturing orthopedic appliance, and it includes by medical grade powder and passes through Increasing material manufacturing process is forming the orthopedic part of increasing material manufacturing.The method also includes being heat-treated the orthopedic part of increasing material manufacturing, and Process the orthopedic part of thermally treated increasing material manufacturing, to form orthopedic appliance.

Another aspect of the present invention is a kind of intramedullary nail, and it includes wall, and described wall includes the one or more of medical grade powder Laser sintered layer.Described wall has outwardly and inwardly, and described inside generally defines the internal prongs region of intramedullary nail.In described marrow Nail also includes the inner passage for housing the miniaturized sensors probe at least a portion extending to wall.In addition, it is internal Sensor probe passage does not extend across the outside of wall.

In addition, one aspect of the present invention is that have to be connected in the marrow of the first section of the second section by telescopic section Nail.Described telescopic section has external diameter, and it is sized to be slidably received at least one of first and second sections Interior zone in, to adapt to the adjustment of the position to axial of the first and second sections.Additionally, the first and second sections are to use Structure in implantation bone.Described intramedullary nail also includes mechanical actuator, and it is adapted to provide for bias force to bias first and second The position to axial of section.

Another aspect of the present invention is a kind of intramedullary nail, and it includes thering is wall outwardly and inwardly, and described inside generally limits Determine the interior zone of intramedullary nail.Described intramedullary nail also includes the first screw hole and the second screw hole, described first and second screws Hole extends at least across the outside of wall.In addition, intramedullary nail includes one of wall between the first and second screw holes or many Individual projection, one or more of projections at least do not extend across the outside of wall.Additionally, one or more projections are configured to change Become torsion and the bending modulus of intramedullary nail.

Another aspect of the present invention is a kind of intramedullary nail, and it has the first section with wall, and described wall substantially limits The interior zone of a part.Described intramedullary nail also includes the second section being connected to inner segments, the size of described inner segments It is set for lateral displacement at least a portion of the interior zone of the first section.Additionally, inner segments are passed through to lock spiral shell Nail is optionally detachable from the first section, to selectively change the mechanical performance of intramedullary nail.

Brief description

Description herein refer to the attached drawing, wherein in several views, identical reference represents identical part.

Figure 1A shows the three-dimensional of the imaginary construction procedures of vertical stacking with 143 nails（3D）Equidistantly the regarding of model Figure.

Figure 1B shows the three-dimensional of the imaginary construction procedures of vertical stacking with 143 nails（3D）The top view of model.

Fig. 1 C shows the three-dimensional of the imaginary construction procedures of vertical stacking with 143 nails（3D）The side view of model.

Fig. 2A shows the direct metal laser sintering with 30% porosity（DMLS）The remote location mid-shaft of intramedullary nail Microscopic view.

Fig. 2 B shows the nail fracture location after 4 points of flexural fatigue tests at the distal position of intramedullary nail.

Fig. 3 A shows the ALM nail manufacturing with processing request after minimum, and all designs opened in cad file are special Levy.

Fig. 3 B shows the ALM nail closing all design features manufactures in cad file and for keeping this part Supporting construction in the chuck of CNC machine.

Fig. 3 C shows the ALM nail manufacturing in the case that the far-end in cad file closes design feature.

Fig. 4 shows the time building nail on SLM500, SLM500 and the size followed closely（Length）Approximately linearly scale.

Fig. 5 shows that the example of 16 prods builds the comparison of time, including building 280 millimeters using different machines （mm）The time of high intramedullary nail and the interpolation of cost.

Fig. 6 A shows using the vertically-oriented perspective view manufacturing intramedullary nail.

Fig. 6 B shows that use level orientation manufactures the perspective view of intramedullary nail.

Fig. 7 A shows the three-dimensional including conical inboard wall section in sectional view（3D）CAD intramedullary nail model.

Fig. 7 B illustrates three-dimensional with partial perspective（3D）CAD intramedullary nail model, and it includes in the wall of intramedullary nail Porous or channel interior structure.

Fig. 7 C is to have an X-rayed, broken section illustrates the three-dimensional including detachable inner segments（3D）CAD intramedullary nail model.

Fig. 7 D with partial cross illustrate including inside have the three-dimensional of groove portion section（3D）CAD intramedullary nail model.

Fig. 8 shows the example of the optimal cross section geometric configuration of intramedullary nail.

Fig. 9 shows the laser sintered increasing material manufacturing successively reproducing from the construction of execution on Renishaw SLM250 The schematic diagram of procedure parameter.

Figure 10 A shows the cross section of intramedullary nail, and it highlights the winding displacement in the wall segment being associated with double scanning strategies Region.

Figure 10 B shows the unidirectional X being associated with the double scanning strategy of the laser sintered layer constructing for refuse And Y scan.

Figure 10 C shows multi-direction with what the double scanning strategy of the laser sintered layer constructing for refuse was associated X and Y scan.

Figure 10 D shows the parameter of the sinter layer using double scanning strategy refuse constructions.

Figure 11 A shows the cross section of intramedullary nail, and it highlights the wall segment of intramedullary nail, described wall segment with for again X the and Y alternate winding displacement laser grating of double scanning strategies of laser sintered layer of fusing construction is associated.

Figure 11 B shows that X and Y being associated with the double scanning strategy of the laser sintered layer constructing for refuse is handed over For winding displacement laser grating.

Figure 11 C shows the cross section of intramedullary nail, and it highlights the wall part of intramedullary nail, this wall part with for again melting The circumferential laser grating changing double scanning strategies of laser sintered layer of construction is associated.

Figure 11 D shows that the circumference being associated with the double scanning strategy of the laser sintered layer constructing for refuse is swashed Light grating.

Figure 12 shows the processing of Ti-64 adding layers（“ALM”）Partial tup stress distribution.

Figure 13 shows the threedimensional model of the ALM part of detecting of the far-end attempting clone's standard intramedullary nail.

Figure 14 shows the example of the laser power of the function as the position along the ALM sample impact to porosity.

Figure 15 shows from being sintered to 400 watts（W）ALM section laser break surface collection SEM image.

Figure 16 shows and is depicted in 5 hertz（Hz）Under carry out four-point bending test result form.Ti by processing 6-4 nail cuts into similar length and uses 300 to 3000 Ns（N）Method tested, to verify, be there is the testing stand of short nail Use.Nail survival 10⁶In the individual cycle, without damaging sign, and do not move on testing stand.Using identical method but make With 200 to 2000 Ns（N）Loading condition test ALM sample.

Figure 17 shows laser power to 5 hertz（Hz）Load 2000 in stepping:200 Ns（N）Under the Ti-64 that carries out The impact of the four-point bending fatigue behaviour of ALM part.

Figure 18 provides the list of the example machine supplier of the laser sintered of Ti-64 material and electron-beam melting.

Figure 19 A shows the 2D figure of the test sample geometric configuration of simplification.

Figure 19 B shows the photo of the rear processing/heat treatment of intubation Ti-64 sample.

Figure 20 shows the four-point bending of the sample of the laser sintered of the function as machine suppliers and electron-beam melting Fatigue behaviour.Test 200-2000 ox, 5 hertz（Hz）Under carry out.

Figure 21 A and Figure 21 B shows the microcosmic section of the EOS sample under different magnifying powers, and uses Kroll's reagent It is etched so that grain structure visualizes.

Figure 22 shows that the HIPPED of the function as machine suppliers is laser sintered and 4 points of electron-beam melting sample Fatigue property.Test is at 300 to 3000 Ns, 5 hertz（Hz）Under carry out.

Figure 23 A shows the Grade producing on EOS M280 machine before hip treatment as manufacture part The crystal structure of 23 titaniums.

Figure 23 B shows the portion that Grade 23 titanium of Figure 21 A after part is already subjected to hip treatment produces The crystal structure of part.

Figure 24 shows the beta transus temperature being heated to 1005 DEG C and with 100 DEG C min-1 to 700 DEG C of speed cooling, stable 2 hours, the generally orderly structure of the conventional flake type Ti-6Al-4V titanium wrought alloy then cooling down in an oven.

Figure 25 provides and completes the surface smoothness of part or the form of roughness through process later.

Figure 26 provides the average measured thickness of α thin slice in studied ALM sample.

Figure 27 provides the key parameter of the fatigue behaviour determining thin slice Type Titanium Alloy.（D）=granular size,（t）=thin slice Width,（d）The size of the colony of=parallel thin slice.

Figure 28 shows that the surface of the function as machine suppliers polishes and electron-beam melting laser sintered with HIPPED The four-point bending fatigue behaviour of sample.With 5 hertz under 400 to 4000 Ns（Hz）Tested.

Figure 29 shows that the load of the ALM part of heat treatment and non-heat treated extends curve.Point F and J represents non-heat treated Partial performance.These parts are firm but crisp.

Figure 30 shows the intensity from forging and ALM Ti-64 part capture（UTS）And ductility（% percentage elongation）Data.

Figure 31 shows the intramedullary nail producing 100 complete density using single, double and four laser instruments with normal scan speed Calculating.

Figure 32 shows the calculating of the intramedullary nail producing 100 complete density with super scanning speed.

Figure 33 A shows the production cost of the every step manufacturing 100 intramedullary nails using standard scan condition（$）Example Property decompose.Assume：- run $ 97 of cost=per hour of ALM machine.The cost of implantation level powder=every Kg $ 255.Manufacture 100 Nail builds the time in 96 hours.

Figure 33 B shows the production cost shown in Figure 27 A, as the percentage cost of each manufacturing step.

Figure 34 A shows using the condition of scanning system higher than the condition of scanning related to the example shown in Figure 31 A-32A Make the exemplary decomposition of the production cost of 100 intramedullary nails.

Figure 34 B shows the production cost shown in Figure 34 A, as the percentage cost of each manufacturing step.

Figure 35 shows the near-end of Trigen Meta tibia nail, and highlights the concept of boundary layer scanning.

Figure 36 A shows the model of the orthopedic intramedullary nail after boundary scan, and it is dimensionally adjusted to examine Consider dimensional contraction.

Figure 36 B shows the model of the orthopedic intramedullary nail after HIPPING, and cad file part needed for its instruction meets is advised The complete tight section of model.

Figure 37 A shows that display " is shelled in situ by 5% boundary scan（In situ shelling）" the powder core that produces Photo.

Figure 37 B CAD shows cad file, and it highlights for preventing residual powder from core after removing from structure plate The distally extruding section of heart effusion.

Figure 38 shows after heat treatment the optical imagery that the burnishing surface of the distally wall segment of end obtains.The hole recording Gap rate and average cell size respectively about 0.25% and 3.4 microns.

Figure 39 A show super laser scanning after orthopedic intramedullary nail model, and its be dimensionally adjusted with Consider dimensional contraction.

Figure 39 B shows the model of the orthopedic intramedullary nail after HIPPING, and its cad file portion needed for instruction satisfaction The complete tight section of sectional specification.

Figure 40 shows and stands variable sweep strategy（Full skin, coreless, full skin, part core）SLM solution produced ALM part four-point bending fatigue behaviour.

Figure 41 shows the sagittal sectional through HIPPING baking oven, and it highlights ALM and is partially exposed to silver-colored steam.

Figure 42 shows the schematic diagram of bead injection program, and it highlights during finishing operations deposition of silver to work department On part.

Figure 43 A shows the three-dimensional of the intramedullary nail with built-in channel（3D）Model, described built-in channel is roughly parallel to Intubation extends with interim collecting sensor probe.

Figure 43 B shows with built-in channel（Diameter 1.5mm）Nail microCT image, it highlights in construction There is no residual powder afterwards in the channel.

Figure 44 shows the three-dimensional of removable sensor probe（3D）Model, it can be designed to shown in Figure 43 Operate in the built-in sensors probe passage of intramedullary nail.

Figure 45 A and Figure 45 B shows the model of intramedullary nail, and this intramedullary nail has and is being suitable to the intramedullary nail of traditional manufacturing technology Near-end and outer surface in formed open channel.

Figure 46 A shows can be using the exemplary geometric configuration of the internal sensor probe passage of increasing material manufacturing generation End-view.

Figure 46 B shows can be using the exemplary geometric configuration of the internal sensor probe passage of increasing material manufacturing generation Isometric view.

Figure 47 shows the nail of increasing material manufacturing, and it includes internal sensor probe passage.

Figure 48 shows the perspective view of the near-end of the intramedullary nail constructing by increasing material manufacturing, and it include being suitable to reception can The built-in probe passage of the insertion of the sensor probe removing.

Figure 49 shows the perspective view of the far-end of the dynamic intramedullary nail of the exemplary embodiment according to the present invention.

Figure 50 A, Figure 50 B and Figure 50 C show to have at the distally of intramedullary nail, mid portion and proximal region respectively and stretch The dynamic intramedullary nail of contracting part.

Figure 51 shows the example of linear processes spring force-displacement relation.

Figure 52 A and Figure 52 B provides mobilism in long bone fracture, activates can re-absorption gathering of the intramedullary nail loading The schematic diagram of the degraded of compound.

Figure 53 A and Figure 53 B shows the dynamic intramedullary nail with telescopic section, and it is configured to correspondingly carry for intramedullary nail For unidirectional and two-direction moving.

Figure 54 and Figure 55 shows the dynamic intramedullary nail with telescopic section, and this telescopic section includes prominent in pin-shaped formula Rise.

Figure 56 shows the impact of the mechanical stiffness measurement to intramedullary nail for the wall thickness.

Figure 57 shows the perspective view of the example of three bushings, these three bushings be configured to intramedullary nail be used together with Repeated loading is partly produced at fracture site.

Figure 58 A shows the outside longitudinal direction view of the end with the intramedullary nail that can activate shape memory sleeve pipe or the collar.

Figure 58 B and Figure 58 C shows the perspective view of the inside of the intramedullary nail shown in Figure 58 A, and it includes being respectively at activity Activated shape memory sleeve pipe or the collar with inactive state.

Figure 59 shows the schematic diagram of each several part of the dynamic intramedullary nail of the biasing element of the encapsulation relative including a pair.

Figure 60 shows the example of the cross-sectional geometry of standard circular section intramedullary nail and intramedullary nail, these cross section geometrics Shape can reduce the bending stiffness in anterior-posterior plane, simultaneously relative to keep orthogonal in rigidity in m- medial plane.

Figure 61 A and Figure 61 B shows based on standard 10 mm outer diameter Trigen Meta tibia nail with the outer surface of nail There is the torsion of 10 mm outer diameter Trigen Meta tibia nails and the bending stiffness data of various sizes of groove.

Figure 62 show in cross section three-dimensional（3D）CAD intramedullary nail model, it includes in taper at the intermediate section of nail Wall.

Figure 63 shows that sign has the theoretical bending of the intermediate section of the intramedullary nail of conical inboard wall and the table of torsional rigidity Lattice.

Figure 64 A shows the three-dimensional of intramedullary nail（3D）The fragmentary, perspective view of CAD model and sectional view, this intramedullary nail is in nail Equipped with interior groove circumferentially in inwall section.

Figure 64 B shows the sectional view of a part for the intermediate section of the intramedullary nail shown in Figure 65 A.

Figure 65 illustrates the three-dimensional of intramedullary nail with broken section（3D）CAD model, this intramedullary nail is included in marrow inwall Ordered porous or channel interior structure in wall.

Figure 66 shows the end-view of the part from the intramedullary nail shown in Figure 65 that the intermediate section of intramedullary nail is taken.

Figure 67 shows standard intramedullary nail and the intramedullary nail with porous or channel interior structure as shown in Figure 66 and 65 Theoretical bending stiffness and torsional rigidity comparison.

Figure 68 show offer cancellous bone, collagen, Ti 40% porosity, cortex bone, TI-6AI-4V 40% porosity, Ti alloy, the elastic modelling quantity of the data of CO-Cr alloy, steel and Ti-6A-4V are to density map.

Figure 69 shows the three-dimensional of the intramedullary nail including detachable inner segments（3D）The perspective of a part for model, locally Sectional view.

Figure 70 shows offer standard Trigen Meta tibia nail and has the detachable inside similar with shown in Figure 69 The form of the comparison between the bending of the nail of section and torsional rigidity.

When read in conjunction with the accompanying drawings, it is better understood with the following of foregoing summary and certain embodiments of the present invention Describe in detail.In order to the purpose of the present invention is described, some embodiments shown in the drawings.It is to be understood, however, that this The bright arrangement being not limited to shown in accompanying drawing and instrument.

Specific embodiment

In order to promote the understanding of the principle to the present invention, referring now to the embodiment shown in accompanying drawing, and will use Language-specific is describing these embodiments.It will be appreciated, however, that the scope of the present invention not limited to this.In neck involved in the present invention The technical staff in domain would generally be it is contemplated that any change in described embodiment and further modification, and herein Any further application of the principle of the described present invention.The non-restrictive form of the present invention and the following description of embodiment It is inherently exemplary it should be appreciated that relative description and explanation are in no way intended to limit public affairs herein with explanation The present invention opening and/or its application and purposes.

Orthopedic appliance needs some material characters and/or tolerance, for optimal under the stress loading condition in human body Manufacture and performance.For fixing device, such as in marrow（IM）It is tired, curved that nail, this property or characteristic can include four-point bending Bent modulus, torsional rigidity, tensile strength/ductility/yield strength, porosity, surface smoothness and geometric tolerances/part essence Degree.Although the Ti-64 nail of traditional forging/processing can meet current desired standard, with Rapid Manufacturing Technology（RMT） Appearance, exist and relatively prominently reduce raw and goods holistic cost chance.Additionally, the implantable dress being manufactured using titanium The world market put is sold estimation and will be reached 26,000,000,000 dollars in the year two thousand twenty, this address and needs change manufacturing process pre- to meet The amount of phase.Additionally, increasing material manufacturing has the advantages that the product/part providing near-net shape to multiple markets, high without relying on The labour of technical ability.Furthermore, it is contemplated that its design freedom, make in the implanted device of design and manufacture such as intramedullary nail etc The possibility for the feature specific implant of exploitation to patient can be opened with increasing material manufacturing, described feature includes for example suffering from The age of person, bone mass and type of impairment and other features.

RMT technology includes but is not limited to direct metal manufacture（DMF）, direct metal laser sintering（DMLS）, electron beam weldering Connect（EBM）With solid freeform manufacture.These technology have been used to various industries, including for rebuilding, wound and rehabilitation dress The orthopaedy put.In general, DMLS can be using three-dimensional（3D）CAD（CAD）Model, it can pass through journey Sequence creates, such as Materialise^®Magics^®, to produce by irradiating, with laser, three Vygens that metal dust successively produces Belong to Sintering Model.For example, Figure 1A -1C respectively illustrates by Magic^®The three-dimensional of the imaginary construction procedures of program creation（3D）Model Isometric view, top view and side view, this program has in 25 centimetres of 25 cm x（X is multiplied by y）Construction plate on 143 The vertical stacking of nail.

However, the use of DMLS can produce the flagrant many related to material property and function in orthopedic appliance Problem, including porosity, part tolerance, Element Design and surface smoothness, this needs extra post processing, and each of which will Summarize in turn below.

（A）Porosity：The laser-light beam device of suboptimum can produce concrete dynamic modulus region in material, and this leads to the material of difference Material characteristic and the performance of subsequent bad/reduction.These porosity problems are generally mainly due to un-sintered in manufacture part The capture of the residual gas of powder and during sintering such as argon and oxygen etc.For example, Fig. 2A shows tool at remote location mid-shaft Have a remote axis of the DMLS intramedullary nail of 30% porosity, and Fig. 2 B show the result as 4 points of flexural fatigues tests in marrow The nail fracture location of the correlation at the distal position of interior nail.

（B）Part tolerance：The laser beam of suboptimum（Power）The device that specification exceeds required tolerance can be produced.For example, right In intramedullary nail, this region outside the required tolerance that can be produced by secondary optional laser beam includes the inner/outer part followed closely And the region being associated with internal screw diameter.

（C）Part design：In view of the complex geometric shapes of the wound fixing device of such as intramedullary nail etc, determine and swashing Which design feature should be opened during light sintering stage it is critical that.Equally, identification holding member during rear processing Required suitable support structure designs for final part quality also it is critical that.Fig. 3 A showed in the structure stage Period opens the part of all design features.Relatively thin in view of wall, special to fatigue stress in the design feature of the far-end of part Insensitive.Part generally along vertically-oriented construction, and therefore, the property that the micro-structural around transverse screw hole is radiated due to part Matter and be particularly easy to that defect occurs.Therefore, although needing minimal amount of rear processing, this part design does not produce gratifying machine Tool fatigue behaviour.Fig. 3 B depicts more conservative design, because all of design feature during the structure stage（Cross screw Hole, keyway etc.）Have been off/this part is also in the chuck that near-end is furnished with protuberance so that part is fixed on CNC machine.To the greatest extent Manage this design and create gratifying mechanical performance, but the rear process segment is very intensive.Fig. 3 C depicts implant design Provide the balance between rear process requirements and required mechanical performance.Distally feature is closed in the most fragile part of nail, and this subtracts Lack rear process time, but solve the risk of beginning of fatigue failure.

（D）Additional processing：At present, the most preferably rear DMLS process giving mechanical performance is typically unknown or suboptimum.Skill Art is known in the art, for example：Hip treatment（HIP）, wherein, implant stands temperature and the isostatic pressed gas raising Pressure is to consolidate and to reduce the porosity in material；Peening, wherein, implant is bombarded to produce plastic deformation, and Re-melting sinter layer is for other strategies improving component capabilities to reduce the porosity of growth part.

Additionally, the use of DMLS can produce the many problems related to merchandise cost and productivity ratio.For example, at least some of In the case of, depending on the grade of the Ti-6AL4V powder bought, such as Plasma Rotation electrode process（PREP）, gas atomization With ELI grade 23, the cost of metal dust can be in about $ 200-400/kg.Additionally, machine cost/structure time can be big About $ 97/ hour, size, capital equipment and level of depreciation and staff that this depends on manufacturing cell.In addition, with for example Daily 600 nails（Each nail 2.4 minutes）Compare, it is possible to use the nail of height can be the zero of each component 100 nail to obtain Part handling capacity, can spend to complete within about 109 hours（Each nail 65.4 minutes）Medicine equipment manufacturing cell is carried out Decrement process operation.Can use and there is larger floor space and equipped with 4 scanners（Such as SLM 500 4 line scanner） Laser sintering machine come to improve add manufacturing process efficiency.800 nails（Size 20 centimeter length × 10 millimeter OD）Can be 160 Build in hour, this is equivalent to often follows closely 12 minutes using boundary scan " shelling in situ " strategy.If running to full capacity and adopting Use boundary scan strategy, SLM500 can produce about 40 every year, 000 nail.If can the use of price be the atomization of 30/Kg The supply of powder has precedence over the material providing from powder supplies business（It is usually $ 250-400/Kg）, then the average unit cost of each nail Can be close to every part $ 120.Fig. 4 shows the time building nail on SLM500, SLM500 and the size followed closely（Length）Approximately It is linearly scaled.For example, 320 mm nails need the average often nail construction-time of 25 minutes, Fig. 4.

The cost of metal dust generally by supplier's control, supplier may in some markets limited quantity supplier Collect the charges.For example, with existing titanium production method（For example, the gas atomization of energy-intensive and toxicity Kroll method）Compare, The commonly provided substantially less expensive and eco-friendly powder of European supply company, more specifically supplier of Britain, which constitutes Expensive and labour-intensive four steps process.This supplier can be converted into using rutile and using electrolysis Powder titanium, this is cost-effective and is therefore commonly necessary for supply chain.Low cost titanium powder can be used for multiple In new application, and this metal is for for prohibitively expensive for producing low value article in batches in the past.For example, directly from rod The gas atomized powder of material is the potential route that Ti-64 power cost is reduced to about 3 30/Kg.

Fig. 5 shows to use and is designated Arcam S12, Concept M2, EOS M270, Realizer, Renishaw The example of the comparison of structure time of 16 prods of the different machines of AM250 and SLM Solutions 280HL, including slotting The angle of incidence and cost set up 280 millimeters（mm）High intramedullary nail.The structure time of part may be subject to multiple changes that are mutually related The impact of amount, including such as DMLS machine specifications, and running cost, such as gas, electric power and capital equipment and other become This, shown in example table as shown in Figure 5.Although there may be relatively significant scope to reduce the cost of part manufacture, But, not necessarily compared with the cost processing these parts, this eliminates to such as part design, sweep speed and scanning for it The needs of other cost reduction strategies of pattern.

The present invention is that the orthopedic appliance with the material property being matched with forging/casting/processing titanium part is provided Good DMLS manufactures route.

In a kind of form of the present invention, there is provided a kind of side of the orthopedic appliance manufacturing elongation by Direct Laser sintering Method, it comprises the following steps：a）Produce virtual three-dimensional（3D）Elongated devices model；b）Using at least 300 watts（W）Laser work( Rate, and the powder using at least 5 grades of quality, such as TiAl6v4 powder, according to described three-dimensional（3D）Model, by direct metal Sintering manufactures elongated device along suitable structural grain；c）Described elongated devices are made to stand the temperature using at least 1000 degree High temperature insostatic pressing (HIP)（HIP）, wherein cooldown rate is between 0.24 and 72 degree Celsius of min -1；d）Process and polish the thin of HIP process Growth device；And e）Wherein, mechanical performance is equal to the four-point bending performance of forged titanium.

In another kind of form of the present invention, orthopaedic implant, such as intramedullary nail are manufactured by following steps and process：

（A）The establishment of cad file：By suitable file type（For example .stl formatted file）Along in the orientation being suitable to manufacture Pass to three-dimensional（3D）Software provider, such as Materialise^®Magics^®.Such file can be included in such as marrow （IM）The vertical structure structure of the non-supported of nail, and miscellaneous part or device.

（B）Construction orientation：Part can be set up along from multiple structure orientations of 0 to 90 degree, and this will produce to mechanical load Sensitive anisotropic physical property.They can also using or processing after not assisted using the supporting construction of custom design Process, Fig. 3 b.Additionally, using equipped with the soft adding layers machine being coated with device and not having any supporting construction（“ALM”） Vertically build the part of such as intramedullary nail etc, it is possible to reduce the burden processed afterwards.For example, Fig. 6 A and Fig. 6 B shows use Vertically-oriented（Fig. 6 A）And horizontal orientation（Fig. 6 B）The manufacture of prominent intramedullary nail three-dimensional（3D）Cad file, wherein, vertically and Horizontal orientation is suitable to there is the soft and hard ALM being coated with device.Fig. 6 A shows the structure part being in vertical construction/orientation, And can be more economical by the supporting construction of design permission stacking part.Fig. 6 B shows according between 0 to 90 degree Angle under construction/orientation structure part, and can aid in reduction their anisotropy behavior.However, it is possible to Manufacture small number of device in single structure in operation.

（C）Design optimization：RMT can be used for giving the internal geometry with regard to intramedullary nail（Fig. 5 A-5D）With outside geometry Shape（Fig. 6）Sizable design freedom, to change nail characteristic, for example, the torsion that is difficult to using common manufacturing method Turn/bending stiffness.Specifically, Fig. 7 A-7D show in cross section three-dimensional（3D）CAD intramedullary nail model, and it highlights Tapered wall section（Fig. 7 A）, cellular internal structure（Fig. 7 B）, detachable inner segments（Fig. 7 C）And internal slotted section（Figure 7D）.In addition, Fig. 8 shows the example of the optimal cross section geometry of intramedullary nail, wherein：A=Solid Schneider, B= Diamond, C=Sampson Fluted, D=Kuntscher, E=Rush, F=Ender, G=Mondy, H= Halloran, I=Huckstep, J=AO/ASIF, K=Grosse-Kempf, L=Russell Taylor, M= Trigen.At least some of these nail geometries can have features designed to the section reducing rigidity or reducing pressure in marrow. Additionally, the diverse range of these nails is from the Kuntscher nail that can be tight fit, fraising, latch-up-free（D）Make to inclusion Universal nail with interlocking screw（K）.

RMT can be also used for producing the implant of patient's coupling by the curvature optimizing intramedullary nail.This can be avoided marrow Interior nail and bone, the radius of curvature particularly between distal femoral mismatch, and this otherwise may lead to frontal cortex to be bored a hole.For example, stock The radius of curvature of bone is estimated as 120cm（+/- 36cm）.However, femur pin design generally has less curvature, wherein, radius Scope is from 186 to 300cm.Additionally, nail can also be designed to be suitable for each individually fracture.According to such embodiment, permissible Creating the computer model of each independent fracture, then can testing different fixed policy using this model, to select The system of specific mechanical environment will be created for the carrying demand supposing.

（D）Three-dimensional（3D）The selection of printer：Intramedullary nail can using from such as SLM Solutions, Renishaw, The various business machines of the supplier of Realizer, EOS, Concept Laser and Arcam are building.Every kind of technology relative Advantage is typically based on：（a）Machine productivity（The i.e. size of chamber（Along x, y and z axes）, sweep speed and number of lasers）；（b） Part quality（I.e. precision, surface smoothness, tolerance/resolution ratio）；And（c）Capital and operating cost（For example, gas and electric disappearing Consumption）.

（E）Laser sintered：Rigid be coated with device, the EOS M270/M280/M290 being for example derived from EOS can produce and has Excellent mechanical performance and the part of the porosity reducing, material that this allows for any weak binding, partially sintering more may be used Can be removed at each techonosphere.The soft device that is coated with may produce the part being likely to be polluted by silicones blade chips, This needs is studied to meet regulation.Soft be coated with device blade after once building may abrasion, this was again to manufacturing Journey increased extra cost.The rigid device blade that is coated with can be made up of high-speed steel, and is discharged into part from these arms Chip be observed and produce less problem than the soft device blade that is coated with.The rigid device blade that is coated with uses also more for powder Economical.The Modern Laser sintering machine being provided by SLM Realizer can produce 30 microns of focusing beam spot size, and it can produce Life has the part of excellent grain structure and resolution ratio, enabling realize novel design feature, such as built-in channel.

（F）Powder specifics：Medical grade Ti-64 powder has multiple different patterns, and this depends on final application and three-dimensional（3D） The selection of printer.5 grades of gases or plasma atomized powder be generally used for laser sintered in, can have 15 to 45 microns（μm） Or 20 to 63 microns（μm）Particle size range, and generally provided with 150/ kilogram of cost.23 grades of ELI powder can be gas Body atomization or centrifugation PREP powder, its particle size range is at 45 to 100 microns（μm）Between, and generally supplied with 250 dollars/kilogram Should, and the low-level oxygen of fall, nitrogen, carbon and/or iron can be contained.Can determine from the QA test of building component and powder bed Determine to be switched to the starting powder for subsequent builds, or using from the previous untapped powder building.Obviously, from previous Build part in the untapped powder that construction is left to reduce cost burden and need to buy several tons of powder to cover greatly Amount intramedullary nail（That is, 10,000 or more）Manufacture.

（G）Build the selection of parameter：In the production of intramedullary nail, in addition to other technologies, it is to melt including selective layer Change（SLM）, the structure parameter that selects of the increases material manufacturing technology of laser sintered and electron beam treatment could be for execution and increases material system The brand of the equipment made or manufacturer are exclusive.For example, the laser sintered or electron beam treatment of Ti-64 is probably lathe supply Business is distinctive.Additionally, Fig. 9 provides the schematic diagram of the structure parameter that can be used for Renishaw SLM250 to produce intramedullary nail.Tool For body, Fig. 9 is the laser sintered increasing material manufacturing procedure parameter successively reproducing from the construction carrying out on Renishaw SLM250 Schematic diagram, wherein, laser power is at 50 watts（W）With 280 watts（W）Between, point distance is at 30 to 90 microns（μm）Between, Winding displacement distance is 65 microns（μm）, thickness degree be 50 microns（μm）, expose（Ex）For 50 to 500 microseconds（μs）.

With regard to scanning strategy although some interpolation manufacturing technologies（Such as selective layer fusing（SLM））Can produce completely Fine and close material, but reducing fractional porosity using one or more of following scanning strategy is probably necessary or beneficial 's：

（1）Layer re-melting：As shown in figures 10a-10d, the re-melting of laser sintered layer can help reduce using double scanning strategies The porosity of growth part.Additionally, in some systems, for example at 1 kilowatt（kW）In SLM Renishaw SLM250 system Variable focus optics is so that at relatively slow rate using high laser power, and can have relatively at the center of layer Big spot size is to compensate high heat loss.Furthermore, it is possible in surface region（That is, the border of layer）Place is using relatively high speed height Laser power, to realize great surface quality.Figure 10 A shows the cross section of intramedullary nail, and it highlights and double scanning strategy phases Winding displacement region in the wall segment of intramedullary nail of association.Figure 10 B shows unidirectional X and Y scan（That is, direction is parallel to each other）, and And Figure 10 C shows multidirectional X and Y scan（That is, direction is transverse of one another with such as 90 degree）.Figure 10 D shows using double Parameter used in the re-melting of the layer of scanning strategy.

（2）Substitute scanning：As shown in fig. s 11a through 11d, it is possible to achieve substitute scanning strategy, for example, by using Realiser SLM 100 system.X and Y that the scanning strategy of this replacement can be included as shown in Figure 11 A and 11B replaces hachure Laser grating and the circumferential laser grating as shown in Figure 11 C and 11D.

（3）On-line monitoring：Ultra low oxygen content can be kept in building atmosphere.When processing reaction material, less than 50ppm Oxygen concentration may it is critical that, and may have sizable contribution to material integrity and mechanical performance.For reality When molten bath monitoring system, by creating SLM and the electron beam identification of database, this database can include various information, for example Laser power, scanning strategy, hachure strategy, and process components parameter can be described to structural member（For example in the marrow of structure Nail）The impact of mechanical performance other information.

（H）The post processing of RMT part：The post processing of RMT part can include but is not limited to following steps or process.

（I）Heat treatment：Heat treatment is carried out to the part being built by increasing material manufacturing technique and can be related to HIPPING（Heat etc. Quiet compact system）, any combinations of the step such as stress elimination and annealing.

（a）HIPPING：High temperature insostatic pressing (HIP) can be used（HIP）To reduce the porosity of metal and to improve the mechanicalness of material Energy and machinability.HIPPING may comprise steps of：

（1）Evacuate/cleaning（For example, 3 times to less than 15mb）；

（2）Keeping temperature：Typical HIP temperature can be for example between about 920 DEG C and about 1000 DEG C, and most preferably temperature Degree can be about 980 DEG C+/ 10 DEG C.If HIP temperature is higher than 1000 DEG C, the part of increasing material manufacturing may by nickel contamination, Because HIPPING equipment is generally made up of nickel-base alloy.This becomes apparent from when HIP temperature is close to 1050 DEG C.This can pass through （a）Part is wrapped in titanium（Ti）In paper tinsel,（b）Place the mean on the alumina plate of recrystallization or box so that titanium（Ti）No Can with based on nickel（Ni）Load board contact, or（c）The part of parcel is placed on sawdust blanket；

（3）Keep pressure（MPa）：For example, the pressure during at least a portion of HIP process is 103MPa +/- 5MPa；

（4）Retention time（Minute）：For example, the duration of 120 minutes+15/- 0 minute of HIP process；

（5）Cooldown rate（DEG C/min）：For example, less than 10 DEG C/min；And

（6）The rate of heat addition（DEG C/min）：For example, less than 10 DEG C/min.

（b）Stress elimination process：Stress elimination can be carried out in stress elimination stove under an argon or in a vacuum furnace. One or more of in addition to other steps, stress elimination process may comprise steps of：

（1）The temperature of increasing material manufacturing was made to be increased to the temperature of rising in Centorr vacuum drying oven in 60 minutes, e.g., from about 800 DEG C temperature；

（2）By increasing material manufacturing structure part high temperature keep predetermined time period, e.g., from about 2 hours；And

（3）The chilling temperature of setting is dropped at a temperature of the structure part of increasing material manufacturing（Such as about 400 DEG C of temperature）When, Disconnect stove heat power and open fire door.The temperature of the structure part from high temperature increasing material manufacturing is reduced to and sets chilling temperature Maximum cooling rate can be but not limited to 55 DEG C/min, and from the chilling temperature setting to basal temperature（E.g., from about 100 DEG C Temperature）Cooldown rate can be relatively slow, e.g., from about 35 DEG C/min,

（c）Annealing：Annealing process may comprise steps of：

（1）In argon inert atmosphere, at annealing temperature e.g., from about 1000 DEG C, the manufacture part manufacturing is heated 2 hours.This temperature Degree is more than 995 DEG C of the beta transus temperature of Ti-64 alloy；And

（2）Nitrogen is quenched to room temperature.Note, 1000 DEG C of heat treatment can be used for being taken into α phase in solution and fully sintered The adjacent powder of part may only be partially sintered.

（2）Process operation：The surface of the outwardly and inwardly geometry of the part for increasing material manufacturing being summarized below changes Entering technology can provide the finished surface improving mechanical performance, and intrinsic generally on most of machining surfaces by eliminating Surface negatively to reduce the risk of germ contamination.Can also aid in from the manufacture part removal sharp edges of increasing material manufacturing and help In smoother, be less devastatingly incorporated in human body, otherwise tissue may be by the damages such as sharp edge or wound.

（a）Process operation-external shape：Optional Surface Finishing step can be used for from increasing material manufacturing below The outer surface building part removes α housing, and this is typical three-dimensional（3D）Printing Ti-64 part.Surface finishing operations also may be used To help make surfacing, improve parts precision, and compression layer is incorporated into first 0.2 millimeter of surface（mm）In.

（1）α shell is removed by sandblasting：Remove α shell, its can be about 30 microns deep, but be not necessarily uniform.Can To remove α shell in a variety of ways, including the abrasion method using alumina medium form.This step can be with base Carry out manually in experience, to observe the spark being produced by α situation, to assist in when substrate is destroyed（That is, when α object When being removed, spark will be off）.In production environment, automation group can be set up, this and then can provide gold evenly Belong to and removing.Mechanical removal has the advantages that to help prepare surface for subsequent operation, and lower one-tenth compared with chemical milling This selection.The geometry keeping the structure part of increasing material manufacturing is likely to provide some challenges, because between α housing and substrate Material removal rate by significant changes.The method can be used for attacking outer surface and the inner surface of intramedullary nail.From this step Material unaccounted-for (MUF)（It is usually 0.2 micron（μm））The correlation model building increasing material manufacturing part and/or cad file will be taken into account External diameter（OD）And internal diameter（ID）In.

（2）Vibropolish：According to the surface appearance after ball blast it may be necessary to roughly grind to part, to go before shot-peening Remove or block peak.This step may insure shot-blast process compression whole surface, otherwise will produce stress concentration without being folded in Rough surface body on risk.

（3）Create the compression layer of residual stress：After removing α shell and preparation surface, peening parameter will be specified To induce optimal compression residual stress layer, maximum magnitude is at about 800-1000 MPa（MPa）, and about 0.2 millimeter（mm）Depth Degree.Figure 12 shows that compression layer will have fine grainiess and effectively postponed initiation and the propagation of fatigue crack. Specifically, Figure 12 shows the typical tup distribution curve of stress of Ti-64 ALM part.The bead tool of sample surfaces Play the role of to increase case hardness, and introduce reduce the beneficial compressed residual of tensile stress felt at surface should Power.

（b）Process operation-inner geometry：Optional Surface Finishing step can be used for completing the interior table of part below Face.

（1）Extrusion honing：Extrusion honing is a kind of inner surface fine-processing technique it is characterised in that making the fluid stream containing abrasive material Cross workpiece, it efficiently performs corrosion.This fluid is generally very sticky, and has the denseness of putty or dough.It is permissible It is particularly used for flash removed, polished surface, forms radius, or even remove material.The property of AFM make its for intramedullary nail, groove, Hole, chamber and other inner surfaces in region of being likely difficult to be reached with other polishings or grinding technics are preferable.

In another kind of form of the present invention, the manufacture of orthopaedic implant can utilize optimal process during part is formed Condition.In one embodiment, the manufacture of orthopaedic implants includes three-dimensional（3D）The fatigue of the optimization of printing Ti-64 part Performance.

（A）Laser power：The mechanical performance of increasing material manufacturing part can depend on building them using how much power, example Energy density as the laser beam for producing part.In general, for bigger, the piece surface that manufactures the energy density of part Fineness is more coarse.This phenomenon is likely due to part " leakage " and and promotes powder to be fused to in the dusty material of surrounding Thermally-induced on the surface of part.Therefore, the energy density increasing laser beam can increase the surface roughness of part with always Body intensity.

For example, a collection of 12 are formed by laser sintered（12）The individual increasing material manufacturing similar to tibia nail distally section Ti-64 sample.Implement following processing conditions using Renishaw 250 ALM：（a）150 mm/second（mm/s）Sweep speed； （b）0 millimeter（mm）Focusing skew；（c）65 microns（μm）Point distance；（d）The open-assembly time of 250 μ s；And（e）120 Watt（W）With 400 watts（W）Between change laser power.This process includes and provides with regard to following relevant information：

（1）Metallography：12 ALM samples are exposed to the laser of the change of 120W, 160W, 200W, 240W, 280W and 350W Power, then carries out axial slices and becomes four parts（S1-S4（Figure 13））；Distally is to nearside）, and according to Figure 13 Schematic diagram uses subsequent metallurgy research.Specifically, Figure 13 shows that the ALM of the far-end attempting clone's standard intramedullary nail surveys The three-dimensional of examination part（3D）Model.

After dicing, it is arranged on cold for the Ti-6Al-4V ALM sample of section in acrylic resin, and use SiC paper （80th, 220,800,1200,2400 granularity）It is polished to 1 micron.Using standard image analysis software from SEM （SEM）Porosity in the wall segment of image measurement sample.According to the SEM image being captured using image analysis software in wall part The middle porosity measuring each section sample.The result of research is summarized in fig. 14, and Figure 14 shows as along ALM sample （S1 to S4（Figure 13））The impact to porosity for the laser power of the function of position example.In wall part mesopore, rate exists Between 0.03% and 1.7%, and tend towards the near-end highest of sample（S4）.In general, porosity is with respect to increase Laser power reduce, thus meaning the consolidation of the improvement of mealy structure.

From being sintered to 400 watts（W）ALM section laser break surface capture SEM image figure 15 illustrates, its It is ductility and the feature of brittle failure.This shows to exist some holes being combined with some unsintered powder in cored structure again Gap rate.Specifically, Figure 15 illustrates from being sintered to 400 watts（W）ALM components laser device break surface capture SEM image. Form is mainly ductility, but the relatively poor machinability due to alloy, the deformation phase around pre-existing crackle It is on duty.

（2）Four-point bending test：With regard to the four-point bending fatigue test method of Medullary fixation device, with reference to ASTM test side Method（F1264-03）.The sample being exposed to the change laser power of 140W, 180W, 220W, 260W, 300W and 400W carries out at 4 points Bend cycles fatigue test.Using two loading conditions, i.e. 200 newton（N）To 2000 newton（N）With 300 newton（N）To 3000 Newton（N）.In addition, the Ti-64 nail of processing is cut into the length similar with the shortest sample nail（77.04mm）, and use 300 Ns （N）To 3000 Ns（N）Method is tested, to verify the testboard using relatively short nail.The Ti-64 nail survival 10 of processing⁶Individual week Phase, there is no the sign damaging, and do not move on testing stand.Using identical method but using 200 Ns（N）To 2000 Ns （N）Loading condition test ALM sample.Record the inefficacy cycle-index of each sample, and sample is taken pictures to record mistake Effect pattern.In all cases, length/diameter（L:D）Ratio is fixed on 7:1, all tests are at 5 hertz（Hz）Under carry out.Survey Test result is summarized in figures 14 and 15, and Figure 16 shows the test result of the summary carrying out under 5Hz, and Figure 17 shows laser Power loads as 2000 in stepping:200 newton（N）, 5 hertz（Hz）Under Ti-64ALM part four-point bending fatigue behaviour Impact.

（B）The laser sintered fatigue criterion performance with electron-beam melting sample：Supplied using specific machine to determine Answer business to build the benefit with the presence or absence of any accumulation during Ti-64 nail, as shown in figure 18, can create and finally device-dependent portion Part geometry, this allows directly to be compared again.Specifically, Figure 18 list for the laser sintered of Ti-64 material and The machine suppliers of electron-beam melting, Figure 19 A shows the 2D figure of the test sample geometry of simplification.Figure 19 B shows letter The photic etching of the test sample geometry changed.

When the ALM Ti-64 sample of general introduction in Figure 19 makes different machine suppliers carry out under " completion condition " at 4 points During repeated bend test, as shown in figure 20, they tend to lose efficacy about 125k cycle.On the contrary, the forging of same geometry Make metal with 4000 Ns（N）It is loaded into 400 Ns（N）With 5 hertz（Hz）1M circulation can be run during loading.When in microscope During lower these ALM Ti-64 samples of observation, find that they are highly porous, show coarse surface, and there is suboptimum Microstructure.More specifically, Figure 20 shows the Ti- of the laser sintered of the function as machine suppliers and electron-beam melting The four-point bending fatigue behaviour of 64 samples.Part geometry：- 100 millimeters（mm）Long × 10 millimeters（mm）External diameter OD and 4.7 Millimeter（mm）Internal diameter）；Test condition：According to ASTM 1264 at 5 hertz（Hz）Under -2000 Ns（N）To 200 Ns（N）.This survey Take temperature bright laser sintered and electron-beam melting sample average behavior be about 125k circulation inefficacy.

With reference to Figure 21 A and 21B, illustrated therein is the typical crystal structure of laser sintered Ti-64 part, it is included in matrix Band β in α, and be Widmanstatten type.Specifically, Figure 21 A and 21B shows the EOS sample under different magnifying powers Micro- section, and be etched with Kroll's reagent.This is very similar to be heated to 1000 DEG C and forcing air to cool down it The forging microstructure producing afterwards.Crystallite dimension is at 100 microns（μm）In the range of.Such structure may will not produce Good mechanical performance, and suitable solution and aging strengthening model may be needed to have acceptable mechanical performance to produce Material.The EOS Ti-64 part being etched with Kroll reagent is in low multiplication factor（Figure 21 A）More high-amplification-factor（Figure 21 B）Under Display crystal structure, shows the Widmanstatten type structure of single crystal grain.

（C）HIPPING：Honing can effectively improve the fatigue behaviour of ALM Ti-64 part, as shown in figure 22. In general, when ALM Ti-64 part at a temperature of 980 DEG C under the pressure of 200MPa with 4 DEG C of initial cooldown rate and 10 DEG C/min of HIPPED carry out 4 little constantly, fatigue behaviour can improve 100%.For the sample being produced by SLM solution Product, when with 5 hertz（Hz）（Not shown）It is carried in 4000 Ns（N）With 400 Ns（N）Between when, 26,891 circulation occur poles Limit is destroyed.Specifically, Figure 22 show that the HIPPED with following parameter is laser sintered and 4 points of electron-beam melting sample curved Bent fatigue behaviour is as the function of machine suppliers：Part geometry is 100 millimeters（mm）Long, external diameter is 10 millimeters（mm）, Internal diameter is 4.7 millimeters（mm）；According to ASTM 1264 at 5 hertz（Hz）Under 3000 newton（N）To 300 newton（N）Test-strips Part；HIPPED initial cooldown rate with 10 DEG C/min under the pressure of 200MPa at a temperature of 980 DEG C continues four（4）Little When.Inefficacy usually occurs in about 200, circulates for 000 time, wherein by the 1M circulation of HIPPED part depletion realizing device generation, Figure 22.

HIP process can refine crystal structure to produce flake structure, when being heated to above beta transus temperature Slow cooling When, with conventionally fabricated titanium, there are some similitudes.Figure 23 A and 23B shows that HIP is processed to 23 grades producing on EOS machine The impact of titanium, wherein Figure 23 A show the part of construction, and Figure 23 B shows the part after HIP process.Although the width of thin slice Change with other samples with overall crystallite dimension, but diagram is typical case's modification that the sample observation from other machines is arrived Type.The main distinction with conventional Ti-6Al-4V titanium is the quite unordered property of the thin slice observed in all these samples Matter.Included by the α band of the very little region disconnecting of β with the microstructure that laser sintered part is observed.

As shown in figure 24, conventional sheet type Ti-6Al-4V titanium forms the large area of parallel thin slice in crystal.Specifically For, Figure 24 shows the typical ordered structure of conventional flake type Ti-6Al-4V titanium alloy.The sample that HIP is processed（Figure 23 B）Than Conventional flake type Ti-6Al-4V titanium alloy shown in Figure 24 is more unordered.This contributes to these samples during testing fatigue relatively Low fatigue behaviour.It can also be seen that there are clear and definite crystal boundaries in conventional sample, but in the test sample checking These are difficult to define, because not appearing to significantly distinguish between chip colony and grain boundary.More specifically, Figure 24 Show Ti-6Al-4V titanium alloy, it generally forges and is heated to 100 DEG C of beta transus temperature, with 100 DEG C min-1 to 700 DEG C Speed cooling, stablize 2 hours, then cool down in an oven.

ALM sample carries out HIP process at 980 DEG C, it is therefore more likely that be not reaching to β changing, is therefore not carried out β's Phase transformation.This occur to be combined with slow 10 DEG C of min-1 of cooldown rate explain forge microstructure and the ALM sample studied it Between difference.In order to suitable structure is produced it is necessary to reach beta transus temperature by heat treatment.This will allow to produce in cooling Orderly flake structure.The width of thin slice is determined by cooldown rate, realizes finer structure with cooldown rate faster.? Find, the width of thin slice（t）Should be 3 microns, and parallel thin slice（d）The size of colony should be 30 microns, to obtain maximum Fatigue strength.

If HIP temperature increases to 1000 DEG C, more orderly parallel construction should be realized and change so that realizing complete β. In order to realize the ordered structure of alpha+beta chip type alloy, should be at 0.24 DEG C min-1 and 72 DEG C from the cooldown rate of beta transus temperature Between min-1, cooldown rate produces less thin slice faster.Cooling speed in the HIP stove of the ALM part for this batch Rate is 10 DEG C of min-1, and produced thin slice has the width between 4.05 microns and 6.12 microns, Figure 26.This with The optimum size of big fatigue strength hardly differs.Therefore, if HIP temperature increases to 1000 DEG C, thus realize complete β changing, More orderly parallel construction should be realized.

（D）HIPPING ＆ processing/polishing：The rear processing of part outer surface has the improvement of significant fatigue behaviour.Example As the technology crackle that leads to surface to flatten and reduce in test component of such as abrasive processing etc causes the number at position Amount.As shown in figure 25, stand this after the surface smoothness of external shape through manufacturing part of processing or roughness from 5.43μm（Realizer）- 23.4μmRa（Arcam）Increase to 0.4 μm of Ra after abrasive processing.

The combined effect of HIPPING and outside polishing produces the part with the fatigue behaviour suitable with forged part（That is, When with 5 hertz（Hz）At 4000 Ns（N）With 400 Ns（N）Between load when, 1M time circulate when be finished）, as shown in figure 28.Knot Fruit is it is also shown that by TiAl6V4 Grade 5 material（Higher oxygen content）The ALM part performance manufacturing is good.This result can carry For significant benefit because 5 grades of dusty materials generally compare 23 grades, the cost of material is low 35% so that the method techical and economic assessments with respect to More significant ground more attractive.Specifically, Figure 28 shows that the surface polishing of the function as machine suppliers and HIPPED swash Light sintering and the four-point bending fatigue behaviour of electron-beam melting sample, and there is following parameter：There are 100 millimeters（mm）Long portion Divide geometry, external diameter is 10 millimeters, internal diameter is 4.7 millimeters（mm）；And according to ASTM 1264 at 5 hertz（Hz）Under 4000 Ns（N）To 400 Ns（N）Test condition.Figure 29-30 shows that the load of the ALM part of heat treatment and non-heat treated is prolonged Stretch curve.Point F and J represents the performance of non-heat treated part.These parts are firm but crisp.

The present invention provides at least advantages below with respect to prior art：（1）Mechanical performance similar to forged part；（2） 5 grades of Ti powder can be used, this can provide economic advantages again；And（3）Improve part tolerance.It will be appreciated, however, that these Advantage is exemplary, and limits the scope of the present invention never in any form.

Embodiments of the invention also provide the optimal DMLS for orthopedic appliance to manufacture route, and its manufacturing time may be 1/ 6.In another embodiment, there is provided a kind of by Direct Laser sintering manufacture elongation orthopedic appliance method, including with Lower step：

（1）Manufacture virtual 3D solid outer elongated mounted cast；

（2）Using at least 300 watts（W）Laser power and at least 5 grades of quality TiAl 6 V 4 powder, according to 3D model, Be sintered in suitable structural grain manufacturing elongated devices by direct metal, and wherein, powder only in the outside of model and It is sintered to setting diameter so that internally the core and exterior periphery between is substantially by unsintered around internal circumference Powder；

（3）With more than 4 times of laser sintered normal speed（I.e. 3000 mm/second）Scanning；

（4）Using at least 1000 DEG C of temperature, with the cooldown rate between 0.24 DEG C of min-1 and 72 DEG C of min-1, elongated ALM is filled Put and carry out high temperature insostatic pressing (HIP)（HIP）, therefore ensure that central powder section sinters；And

（5）The elongated devices that HIP is processed are processed and are polished to required geometry and superficial tolerance（For example, 32 Ra μm （Realizer））.

Following two scanning strategies（" surpassing " laser scanning and " boundary scan-bombard in situ "）It is assumed that manufacturing ALM nail Most of cost of commodity is joined with the structure time correlation in DMLS machine.

（A）" surpassing " laser scanning：Retouched from Figure 31 and 32 with the economical advantage that " super scanning speed " operates laser sintering machine The data painted is it is clear that described data is to be equipped with single, double and four scanner optical functions DMLS machines by three to generate.Right In the conventional laser scanning imaging system of single laser system, a collection of 100 nails need to complete for about 4.5 days, are equivalent to every nail 65 minutes （Figure 25）.This can not be compared with from the handling capacity that standard process operation obtains, and it is relatively equivalent to every nail about 2.5 minutes or every It 600 nails.DMLS machine if equipped with four laser instruments is arranged to higher sweep speed operation, then each nail Only need to build within 12 minutes（Figure 32）, so that this technique is significant more attractive in high volume manufacturing（I.e., every year 10,000 parts）.By with higher sweep speed（It is usually laser sintered 3-4 × standard speed；1000mm/s）Behaviour Make, part will only partially sinter（Usually the 50% of the whole volume of part）.The sweep speed of this acceleration is still significant low In sweep speed used in electron beam melting process（1000-8000 meter per second）.This scanning strategy is assumed as follows：a）In heat Any residual porosity staying after building is removed after process；（b）Circulated using standard heat treatment；（c）Draw because part shrinks The change in size rising is taken into account in the original design of cad file or by Magic^®Programme-control；And（d）Super scanning speed portion The mechanical performance divided is equal to normal scan.

Figure 31 shows and generates 100 using single, double and four laser instruments and using following parameter under normal scan speed The calculating of the intramedullary nail of complete density：Section counts=3911；Repainting time=31,288 second；Sweep speed=600mm/s.Figure 32 calculating showing the intramedullary nail for producing 100 complete density under " super scanning speed ", and utilize following parameter： Section counts=3911；Repainting time=31,288 second；And sweep speed=3000mm/s.

Figure 33 A-34B shows the decomposition of the cost of the Ti-64 nail for manufacturing additive manufacture.Fixed cost includes powder End（Assume that current supply chain selects qualified powder it is impossible to obtain the metal spraying equipment of lower cost）, process and pack/go out afterwards The cost of bacterium.The use of the totle drilling cost that this manufacture route manufactures ALM nail is $ 149.50.With the cost of super scanning speed operation to structure Build time cost and have and significantly affect, it is reduced to 25.6% from the 62% of total manufacturing cost, as shown in Figure 33 B and Figure 34 B. Additionally, the cost producing " super scanning " part is reduced to $ 75.90 from $ 149.50, this is equal to the machining of geometry with manufacturing The cost of part is consistent.

Standard scan condition using SLM DMLS machine（Sweep speed<1000mm/s）The production manufacturing 100 nails becomes This is shown as cost decomposition in Figure 33 A（Dollar/manufacturing step）, and Figure 33 B is as the percentage one-tenth of each manufacturing step This, and have it is assumed hereinafter that：The cost running ALM is $ 97/ hour；The cost of implantation level powder is $ 255/kg；And build Time is to manufacture 100 to follow closely 96 hours.

Figure 34 A and Figure 34 B shows and uses " fair speed " condition of scanning for SLM DMLS machine（Sweep speed< 1000mm / s）Manufacture the production cost of 100 nails, show the cost decomposition of each manufacturing step（Figure 34 A）And each The percentage cost of manufacturing step（Figure 34 B）, and using it is assumed hereinafter that：The cost running ALM is $ 97/ hour；Implantation level powder Cost is $ 255/kg；The structure time is to manufacture within 96 hours 100 nails；And heat treatment cycle HIP 6 hours at 1050 DEG C, And subsequently cool down as quickly as possible in atmosphere, subsequently heat-treatment of annealing 6 hours at 840 DEG C, wherein, all heat treatments exist Carry out in inert argon atmosphere.

（B）Boundary scan：Second method for reducing the cost building part in DMLS room is using scanning plan Slightly, its restriction is sintered to boundary layer（That is, the outer surface of cannula part and inner surface）, properly be referred to as " baked bean tank or de- in situ Shell " model.This scanning strategy omits hatching or the core scanning of part.The Trigen of the concept of prominent boundary layer scanning The threedimensional model of the near-end of Meta tibia nail is shown in Figure 35 9.Using this scan method, only the 5% of part cumulative volume Construction platform sinters.Specifically, Figure 35 shows for fine and close Trigen Met tibia nail（Proximal tapered region domain）Outer Layer and internal layer are to reduce the structure border of time or the concept of " baked bean tank " scanning strategy in DMLS chamber.The core bag of part Powder containing free-flowing densified after the heat treatment.In this example, some part design features, such as keyway and groove Screw hole, is closed.

In addition, in certain embodiments of the present invention, intramedullary nail or other kinds of is manufactured by following steps and process Implant.

（I）Boundary scan：Figure 36 A and Figure 36 B shows in the marrow including increasing material manufacturing part 100 after boundary scan The section of nail 110, the part of its prominent size adjusting is to consider blockage effect（Figure 36 A）, final " steady after instruction heat treatment The part of the increasing material manufacturing of HIP processing of nail 110 sizes calmly "（Figure 36 B）.Specifically, Figure 36 A shows and adds the part manufacturing 100, it will provide orthopedic medulla externa nail 110 before boundary scan, and the cad file of instruction size adjusting is to consider dimensional contraction （Generally<5%）, and Figure 36 B shows the orthopedic intramedullary nail 110 after HIPPING, its instruction has specified geometry Tight section completely.With reference to Figure 36 A, manufacture interpolation using the DMLS technology with only boundary scanning method and manufacture part 100. In conventional practice, produce the Sintering Model representing complete intramedullary nail device 110 using various scanning strategies.Proposed In method, by by threedimensional model, more specifically by laser sintered to outer surface 102 and inner surface 104 to desired thickness, permissible Manufacture " the baked bean tank " of increasing material manufacturing part 100, described thickness can be for example at about 100 microns（μm）In the range of.Except not Outside the press-powder core 108 of sintering, internal prongs 106 will be kept using this scan method.With reference to Figure 36 B, HIPPING it Afterwards, nail 110 becomes fine and close by the heat treatment with some adjoint change in size, which reflects during heat treatment step by The amount of contraction of increasing material manufacturing part 100 experience.Generally, provide powder core using the boundary scan strategy as shown in Figure 37 a for nail The heart.Part density with 5% in build chamber is densified.The basal surface of nail is extruded to 3mm, to prevent powder in Magics software End escapes from the far-end of this part after removing from platform, Figure 37 b.Figure 38 shows the hole in the section being retained in part Degree.Generally, the porosity of measurement is 0.3%, Figure 38.Additionally, average cell size is about 3.4 microns, Figure 38.

（II）Super laser scans：Figure 39 A and Figure 39 B shows and scans it in partly middle generation 50% densified super laser Include the section of the intramedullary nail 206 of increasing material manufacturing part 200 afterwards.This figure highlights size regulating nail 206, and it accounts for effect of contraction and arrives Manufacture the additive of part 200, heat treatment（Figure 39 A）, afterwards it may occur that, and HIP process nail 210 instruction heat treatment The size of the final part of " stabilisation " afterwards（Figure 39 B）.Specifically, Figure 33 9A shows after super laser scanning To be used for being formed the additional manufacture part 200 of orthopedic medulla externa nail 210, super laser scanning indicate the cad file of size adjusting with Solve dimensional contraction, and Figure 39 B illustrates HIPPING after orthopedic rear intramedullary nail 210, represents there is the complete of required geometry Full compact components.

With reference to Figure 39 A, manufacture increasing material manufacturing part 200 using the DMLS technology with super laser scanning.In conventional practice In, the Sintering Model representing complete intramedullary nail device 210 is produced using various scanning strategies.In the method being proposed, insert Pipe 202 is surrounded by half sintering core 204.Referring to Figure 39 B, after HIPPING, nail 206 is densified by heat treatment, described Heat treatment has some adjoint change in size, that reflects the amount of contraction of part experience during heat treatment step.

The super scanning part being provided by SLM solution only through heat-treated, and with same steps in this process after The standard scan part producing compares the cycle-index of inefficacy, Figure 40.Super scanning part is made up of three groups of parts：There is press-powder core Full top layer, there is the full top layer of press-powder core, there is the far-end of extrusion allowing part to be heat-treated on construction platform, and tool There are complete epidermis and the part of amount of powder core.When between 3000 and 300N load when, after the heat treatment step, for There is the part of complete epidermis and compressed-core, the average failure cycle is 1,161 +/- 288.After the heat treatment step, right In the part with complete epidermis and press-powder core, the average accordingly rupture cycle with the far-end of extrusion is 34.7 +/- 9.6k.For the part of the core with complete skin and partial scan, the average accordingly rupture cycle after heat treatment step For 180,068 +/- 38.7k, it has the far-end of extrusion.In the fatigue of press-powder core sample after the far-end comprising to extrude The improvement observed in performance is considered as the benefit being produced due to the heat treatment away from panels." base plate " of extrusion prevents Powder is out.Nail is positioned above platform, then declines 2mm（In CAD space）.Assume that HIP will not be with not extruding The nail work on floor is good, because having stress and micro-crack in bottom periphery, this will make them quite " leakage ".In order to compare Purpose, through standard scan strategy（EOS, Arcam and SLM solution）Part be also included within this in figure.As shown by data, portion The part that the fatigue behaviour of core dividing sintering is provided with the EOS standing standard scan strategy is suitable, Figure 40.

In another embodiment of the present invention it is provided that antimicrobial nail.Scanning strategy from the discussion above is real Existing cost savings are so that other cost-effective processes can be included in procedure chart.

In another embodiment of the invention it is provided that silver-colored hip implant.Specifically, as shown in figure 41, exist During HIPPING step, deposition of silver is on hip implant, and can use following methods：（a）The work of silver-plated/coating Part；And（b）Modified compressed media（Argon gas-silver steam）.Two methods use non-line of sight methods to produce silver-colored coated product, its Known have anti-microbial properties.Specifically, Figure 41 illustrates the sagittal sectional by HIPPING stove, and it is partly sudden and violent that it highlights ALM It is exposed to silver-colored steam.This paint-on technique supposes that the silver layer of deposition is thicker than 0.1 millimeter（mm）To adapt to any post processing operation.

In another embodiment of the present invention it is provided that silver-colored coated beads bead.As shown in figure 42, this reality The scheme of applying may be constructed one-step method, and it is directed to use with the silver coating prepared by silvering or the nitric acid silver coating of roasting from the teeth outwards Ceramic particle.Except producing required surface smoothness, particle produces the hard of the silver-titanium dioxide with antimicrobial properties Change layer.Specifically, during Figure 42 is the finishing operations being highlighted on using the silver-colored grid coating or bead injection, silver is in work Make the schematic diagram of the bead injection method of deposition on part.

The invention provides in terms of merchandise cost saving significantly on respect to existing implant and manufacture method.However, It should be appreciated that these advantages are exemplary, and limit the scope of the present invention never in any form.

An alternative embodiment of the invention provides a kind of orthopedic implant apparatus, for example, have the design freedom of increasing material manufacturing Intramedullary nail, and it includes the longitudinal inner passage that can accommodate removable sensor probe, described removable sensing Device probe is configured to be directed at far-end locking hole and near-end lock hole.Orthopedic implant device also can have promotion anterior-posterior（A/ P）Plane and medial lateral（M/L）Stiffness variable in plane and/or the inside that relatively low stiffness implant is provided for larger patient The internal geometry of geometry.An alternative embodiment of the invention provides a kind of minimally invasive side for automation apparatus Method, to provide biomethanics load for healedmyocardial fracture.

（A）The original position distally and proximally sensor probe aiming at for screw hole in operation：Embodiments of the invention include In orthopedic appliance（Such as intramedullary nail）Wall part in produce longitudinal inner passage, it is used for for receiving using increasing material manufacturing The removable sensor probe of registering distally and proximally screw hole.For example, Figure 43 a shows to have and prolongs parallel to intubation 304 The intramedullary nail 300 of the internal sensor probe passage 302 stretched.Additionally, Figure 43 b show built-in logical wall part from having The microCT image of the ALM part capture in road.Do not have in the channel after the structure stage is shown in by the longitudinal cross-section of this part There is residual powder.Figure 48 shows the near-end of the intramedullary nail 300 building by increasing material manufacturing, and it is included in wall part 306 In internal sensor probe passage 302（Figure 43 a）, it is suitable to receive the insertion of sensor probe 308.Passage 302 wraps Including removable sensor probe can be conducive to nearside to lock, because sensor probe is not located in the intubation of nail, thus permitting Permitted surgeon's brill to follow closely and insert the screws in nail 300.

The shape of internal sensor probe passage 302 can use based on the pact being applied by the geometry of intramedullary nail 300 The increasing material manufacturing of bundle is creating.In an illustrated embodiment, internal sensor probe passage 302 is located at the wall portion of intramedullary nail 300 Divide in 306, to guarantee that may be housed in the probe in passage 302 will not be sandwiched in intramedullary cavity during removing.Vertical passage Diameter is about 1.5mm, extends the length of nail and terminates in the surface of distal screw holes.Internal sensor is popped one's head in passage 302 are positioned at the needs that will avoid in wall part 306 welding is covered, complexity and cost that otherwise this can increase manufacture process.

Figure 44 shows the embodiment being designed to the removable sensor probe of operation in this passage 302.Typically Probe and size sensor can include but is not limited to 1.422 millimeters（mm）External diameter, 1.22 millimeters（mm）Internal diameter, 1.12 millimeters （mm）Highly, 0.61 millimeter（mm）Width and 30 millimeters（mm）Long.In addition, sensor probe can be by various different material structures Become, including such as stainless steel or another kind of rigidity or semi-rigid metal material.It can also include potting compound, for example medical treatment Level silicon rubber or epoxy resin, to protect electronic unit from moisture and vibration force.Additionally, printed circuit board (PCB)（PCB）On biography The configuration of inductor components, i.e. two winding ferrites（Also referred to as six degree of freedom tracking transducer）Preferably each other in 180 degree cloth Put.Such construction can make the overall diameter of sensor unit minimize, for example, be reduced to 1 millimeter（mm）, and it can position Pop one's head in passage 302 in internal sensor, its diameter in nail wall is less than 1.5mm.It is locked that the position of passage also allows for nail In far-end or near-end, provide more selection for surgeon first.Probe is also devised to be locked in bone passage in nail It is removed after in 302.Figure 45 A and Figure 45 B shows the model of intramedullary nail 400, and it has and is being suitable to traditional manufacturing technology The passage 402 that proximal end is formed in the outer surface 404 of nail 400.As depicted, the passage in Figure 45 B include removable Sensor probe 406.This design needs welded plate to prevent probe blocked during extracting from bone pipe.

Figure 46 A and 46B shows can be exemplary several using the additional internal sensor probe passage 302 manufacturing and producing What shape, and highlight the position that passage 302 is with respect to neutral axis.According to some embodiments, internal sensor probe is logical The size in road 302 can be minimized, to mitigate the risk of unfavorable wear-out failure.Passage 302 can be made including passage 302 Plane in bending stiffness reduce about 11%, this clinically can not possibly cause any problem.Additionally, in shown model In, as shown in Figure 46 A, " x " axle in the plane of passage 302 experiences the reduction of about the 11% of the moment of inertia.In addition, perpendicular to " y " axle of passage 302 can experience about the 1% of the moment of inertia reduction.Additionally, it is near to internal sensor probe passage 302 End modeling, the moment of inertia and do not have with passage 302 is calculated as X：878.8mm⁴； Y：990.5mm⁴And X：993.9mm⁴； Y： 993.9mm⁴.

Intramedullary nail 300 shown in Figure 43 a can manufacture in a variety of ways, including for example by using laser or Electron beam is three-dimensional（3D）Print.For Realiser SLM100 system laser scanning condition example in Figure 47 shown in table Middle general introduction.In addition, the thickness of the wall 306 of intramedullary nail 300 can increase, for example, increase wall 306, so that at least attempting to prevent Portion's sensor probe passage 302 is in heat treatment（HIPPING）Period deforms.For example, the wall 306 of intramedullary nail can increase so that The external diameter of intramedullary nail increases by 0.5 millimeter（mm）.According to such embodiment, the additional thickness of wall 306 can be in post processing operation Period sacrifices.

In addition, add the use manufacturing can allow to manufacture intramedullary nail 300, and do not use and can lead to from internal sensor probe Road 302 removes exit point or the opening that non-sintered powder is associated.More specifically, micro- CT is in three-dimensional（3D）From test after printing The image that intramedullary nail 300 obtains indicates that the un-sintered powder that internal sensor probe passage 302 is not remained pollutes, Figure 43 b.Cause This, according to some designs, intramedullary nail 300 can not include the such shifting being in fluid communication with internal sensor probe passage 302 Except point or outlet.Do not exist and remove a little or export, it can at least be applied to the remaining non-sintered powder of removal and can help to letter Change the design of internal sensor probe passage 302 and the manufacture of intramedullary nail 300.

（B）Automation nail：One of orthopaedic basic conception is to understand suitable mechanical load accelerating union of bone fracture. , based on the process adapting to, according to this process, skeleton structure constantly optimizes in response to mechanical environment for this, and it is in response to dynamic State rather than static load and occur.More specifically, itself and peak strain amplitude and load frequency dependence.Although in the marrow of routine Nail allows to apply weight bearing power thereon, but due to there is lock screw, thrust is usually isolated by it with compression stress, lock The main purpose determining screw is to prevent from rotating.Further, since the rigid structure of intramedullary nail, intramedullary nail actually may result in due to Fixed range between fracture end and by being applied to the result of the permanent load share in the whole healing cycle in fracture and The fracture situation of the non-healing leading to.

The axial mobilism of conventional static locking intramedullary nail include initial Post operation in outpatient service is arranged two to three The moon removes one or more interlocking screw.The method needs invasive surgical, and generally has about 1 to 5 millimeter（mm）'s Resolution ratio, it is generally determined by the width of the slit in intramedullary nail, and may only one of intramedullary nail partly in available. The intramedullary nail of automatic power by overcome in these defects some, and divided by the load that continuous adjustment is applied to fracture site Load accelerates the progressively improvement of knitting to provide.Additionally, automatic power intramedullary nail can by the fracture end of permission bone toward each other Suitable axially-movable helping prevent the delayed union of fracture or the generation of disunion.

According to some embodiments, exploitation automatic function intramedullary nail may include following：

（1）Scalable intramedullary nail assembly：Figure 49 shows the far-end of the power intramedullary nail 500 of the illustrated embodiment according to the present invention Perspective view.As illustrated, power intramedullary nail 500 includes Part I 502a and Part II 502b.Additionally, dynamic intramedullary nail 500 are constructed such that the axial location of at least one of Part I 502a and Part II 502b can be with respect to first In point 502a and Part II 502b at least another is adjusted.Part I 502a and/or the axle of Part II 502b May be adapted at least adjust the total length of dynamic intramedullary nail 500 to this change relatively of position.

In embodiment shown in Figure 49, power intramedullary nail 500 includes telescopic section 504, and it is suitable to promote in power marrow The displacement to axial of the Part I 502a and/or Part II 502b of nail 500, and keep first and segmented portion 502a, 502b.For example, as shown in Figure 53 A, according to some embodiments, telescopic section 504 can be from Part I 502a or second The end of point 502b extends and is received within the interior zone 506a of Part I 502a or Part II 502b, in 506b Sleeve pipe first and second part 502a, another in 502b.In embodiment shown in Figure 53 A, Part I 502a's is outer The size of the end 503 of wall 505 can reduce so that a part for outer wall 505 is sized to be received within second 502b in the interior zone 506b dividing.Additionally, according to some embodiments, outer wall 505 is at the end 503 of Part I 502a Diameter can reduce 1.5 millimeters（mm）Diameter is no more than more than 15 millimeters so that the outer wall 505 at end 503 has（mm）, its Interior zone 506b can be less than wherein will accommodate at least one of diameter of the part of end 503.Or, such as Figure 53 B Shown, telescopic section 504' can be to be slidably received in the first and second parts 502a, the interior zone 506a, 506b of 502b In separate part.

In addition, as shown in Figure 50 A-50C, telescopic section 504 may be located at the various difference positions along dynamic intramedullary nail 500 Put.For example, as illustrated, telescopic section 504 can be in distal region（Figure 50 A）, mid portion（Figure 50 B）Or proximal region （Figure 50 C）.This various positioning can promote the continuous dynamic load of different types of fracture.

According to some embodiments, telescopic section 504, the far-end 508a and/or near-end 508b of 504' can include one or many Individual guiding piece or pin 510, its can assist in keeping first paragraph 502a or second segment 502b along or, according to other embodiment, From first or Part II 502a, the inwall 514 of 502b extends, and wherein telescopic section 504 is slidably held for guiding piece or pin 510 It is contained in wherein.According to other embodiment, telescopable portion 504, the outer wall 516 of 504' can be with respect to cooperation interior zone Being sized, telescopic section 504 slidingly receives wherein for 506a, 506b, to prevent the first and second parts 502a, 502b is along central longitudinal axis 512.

With reference to Figure 53 A-55, wherein slidably receive the interior zone 506a of telescopic section 504,506b may include one Or multiple projection 518, it is configured to limit the axial displacement of telescopic section 504.For example, according to some embodiments, projection 518 May be positioned at least limit first and/or Part II 502a, 502b can in the way of reducing the length of power nail 500 axially The degree of displacement.Additionally, according to some embodiments, 518 can be to limit the first and second parts 502a, one of 502b Or two can by increase power nail 500 length degree in the way of be positioned at interior zone 506a, in 506b.Projection 518 can To take various different forms, including e.g. by machanical fastener 520（Such as screw or pin）And other projections 518 The packing ring being held in place by with securing member 520.Embodiment according to Figure 54 and Figure 54, as shown in figure 55, projection 518 Can extend through the first and second parts 502a, one of 502b and be received in telescopic section 504,504''s is outer Pin in the slit 522 of wall 516.According to such embodiment, the size of groove 522, such as length, first and second can be limited Part 502a, one of 502b or the distance that both can be displaced relative to each other.Additionally, as shown in Figure 53 A, according to some Embodiment, axial displacement can be by first or Part II 502a, and the shoulder 524 of 502b limits, and this shoulder 524 is more than another portion Divide the adjacent inner regions 506a of 502a, the size of 506b, 502b.

（2）The actuating that actuator controls：Activating nail 500 can be equipped with least one mechanical actuator 526, and it can be inclined Put and/or affect to activate the orientation of nail 500.For example, according to some embodiments, actuator 526 can be spring, and it is to the first He The opposed area applying power of Part II 506a, 506b with extend or compression power nail 500 length.With reference to Figure 53 A, according to certain A little embodiments, actuator 526 can be spring, and it is configured to make power against the shoulder 524 of Part I 502a and against the The end wall 528 of two parts 502b.Additionally, with reference to Figure 53 B and 45, according to other embodiment, actuator 526 can be respectively to first With Part II 502a, the end wall 528a of 502b, 528b applying power.

In addition, actuator 526 can be can be substantially spring linearly or nonlinearly, as shown in figure 51.With linear Spring is compared, and non-linear or variable bit rate spring can provide enhanced control and support to prevent excess impact power to be applied to Epiphysis.The example of nonlinear spring includes but is not limited to volute spring, and the wire spring of variable pitch or variable-diameter.Public Formula 1 represents general nonlinearity spring force displacement relation：

K=Ko+Kn (formula 1)

Wherein K is spring rate, and Ko is constant rate of speed（Linear segment）, Kn is displacement（Non-linear partial）Function.In addition, According to some embodiments, actuator 526 may further include surge tank, and it for example can be used together with spring to provide more All even stable displacement, to stablize bone end displacement during weight bearing.

Actuator 526 or the combination of actuator 526（Including the spring with other types of actuator set）Can promote or Otherwise allow the axial movement suitable with the displacement that can be caused by the conventional mobilism of distal screw.For example, according to certain A little embodiments, actuator 526 can promote about 1 to 5 millimeter（mm）Axial displacement.In addition, this onboard actuator 526 May also provide controlled circulation compression stress, control the size in the gap between the end of fractured bones, and provide adjustable Intramedullary nail hardness, thus at least helping manufacture the carrying out with healing for the nail 500, is more suitable for the bone of surrounding.

Figure 52 A and 52B provides the schematic diagram of the power nail 600 of the load of actuation in long bone fracture, and highlighting can be again The degraded of absorbing polymeric.The degraded of resorbable polymers can also allow embedded actuator 626 to engage in time simultaneously And discharge one or more bioactivator that can stimulate union and/or reduce infection.According to some embodiments, activate Device 626 can be accommodated in can spring in resorbent biocompatible polymer encapsulation object（Constant or variable bit rate）, its Control spring-compressed or glassy not resorbable polymers simultaneously, for example, be externally exposed applying sensing heater.Properly Can the example of resorbent biocompatible polymer can be including but not limited to poly-（Caprolactone）, gather（Lactic acid）With poly-（Second Alkyd）, and other can resorbent biocompatible polymer.Actuator 626 can be placed in actuating by the degraded of polymer The relaxed state of device 626, thus to the bone 632a of fracture, 632b provides continuous cyclic loading.Or, made by sensing heating Glassy polymers relaxes and spring also will be allowed to respond under cyclic force.According to this situation, when power is applied to construction, can prop up Support fractured bones 632a, the end 630a, 630b of 632b.When polymer encapsulated part is no longer able to bear due to sensing heating or degeneration The load of result when, bone section 632a, 632b can be moved relative to each other.If removing sensing heater, glass from limbs Resorbable polymers can not prevent the motion of spring, thus allowing polymer crystallization and hardening to glass shape.This machine can be optimized Structure is to promote only compression failure gap 634, thus not hindering knitting, if fracture gap 634 is stretched and epiphysis Portion 630a, 630b are opened, then can postpone knitting.

Or, actuator 626 can be encapsulated in its extension state it is allowed to two osteocomma 632a, and 632b is in polymer bag It is pulled together during sealing degraded.Actuator 626 and/or polymer encapsulation also can be filled with activating agent or molecule, to help The bacterial colonisation promoting union and/or reducing implant 600 using growth factor.Such activating agent can include but not It is limited to heavy metal ion, for example golden and silver-colored.

According to another embodiment, the actuator 626 of polymer encapsulated passes through physical energy（For example hot, ultrasonic wave or electricity） Applications periodically activate.Such activation can help to change the physical property of polymer encapsulation object, for example, bend The Young's modulus of modulus and other property.This change of the physical property of polymer encapsulation object can change polymer encapsulating Thing be in wherein polymer encapsulation object at least contribute to stop or otherwise opposing nail 600 Part I 602a and/ Or the state of the displacement to axial of Part II 602b, the compression of length or the expansion of power nail 600 can be additionally resulted in.Cause This, the movement of actuator 626 can provide on demand.

The telescopic section 504,604 of dynamic intramedullary nail 500,600 can be developed to so that it provides unidirectional or two-way putting down Move, such as respectively as shown in Figure 53 A and 53B.Additionally, telescopic section 504,604 and the nail being connected to telescopic section 504,604 The rotation of 500 other parts can prevent from being similar to by groove 530 internally the inner side and outer side direction of part or sleeve pipe 532 Groove 820 and cooperating recesses 822 example also shown in Figure 58 A.Or, aforesaid protuberance 518（For example screw or Pin）The machining groove 522 that extends through in the interior section of intramedullary nail 500,600 of insertion can be used for preventing first and second Divide 502a, the rotation of 502b, keep mechanical actuator 526 to be located in the sunk area of nail 500 simultaneously.In this case, Projection 518 mechanically can also be adjusted by surgeon with the displacement of control machinery actuator 526.In addition, projection 518 can position To prevent fracture gap from increasing in nail 500.

Figure 56 shows the impact of the mechanical stiffness measurement to three intramedullary nails for the wall thickness, that is,（1）Standard is followed closely,（2）In nail The section of external diameter in have machining recess nail, its provide 25% He（3）In a part for the internal diameter of nail, there is machinery The nail of processing part, described nail reduces the internal diameter of nail in the recessed portion of described nail, in the internal diameter of described processing department office nail Size increase by 25% nail.More specifically, Figure 56 shows for four external diameters, that is, a diameter of 13,11.5,10 and 8.9 millimeters （mm）The measurement of each of the nail of three above-mentioned identifications rigidity.Result shows, with the internal diameter increasing intramedullary nail Split-phase ratio, the external concavity part in the outer surface of processing intramedullary nail is to form telescopic section to the mechanical bend rigidity reducing nail There is more significant effect.For example, for 13 millimeters（mm）The nail of diameter, increase nail the internal diameter of a part size by follow closely Rigidity is from 42,000 experienced pound per square inches of standard nail（PSI）Being reduced to rigidity is 29,000PSI, such as comprises to have relatively The nail of the machining interior zone of large diameter is experienced, and for the nail including sunk part in external diameter, it subtracts further The little rigidity to 7,000PSI.Therefore, compare with the actuator on the outer surface being positioned at intramedullary nail 500,600, by actuator （For example, the actuator 526,626 shown in Figure 52 A-53B）It is contained in the inside of intramedullary nail 500,600, follow closely 500,600 is right Fatigue behaviour has minor impact, and can construct by using increasing material manufacturing.

（3）The actuating activating-controlling：According to some embodiments, as above for the cause that at least Figure 52 A-53B is discussed Dynamic device 526,626 can be configured for partly producing the sleeve pipe of repeated loading at fracture location.Bushing can be by various materials Material is constituted, including such as elastomeric material, such as rubber, and other materials.Additionally, according to some embodiments, bushing is permissible Replace the actuator 526,626 of at least some of type, for example variable spring.Additionally, as shown in figure 57, bushing 700a-c can have There is wall 702, this wall generally defines the interior zone 704 of bushing 700, and it a size of receives first and/or Part II At least a portion of 502a, 502b, 502b, 602a, 602b.Also as shown in figure 50, the outside of wall 702 can have various shapes Shape and size.

（4）Actuating-spring and shape memory collar assembly：According to some embodiments, dynamic intramedullary nail 800 can also wrap Include and can activate shape memory sleeve pipe or the collar 802, as shown in Figure 58 A-58C, it is configured to control actuator 804, for example, control Make the displacement being stood by spring actua and be applied to making a concerted effort on bone.As shown in Figure 58 A-58C, according to some embodiments, cover Pipe or the collar 802 can position around the telescopic section 806 of nail 800, and telescopic section 806 is sized to be contained in first , according to illustrated embodiment, first end 814a of sleeve pipe or the collar 802 is permissible for the interior zone 812 of point 810a and/or Part II It is positioned to the abutting end of contiguous actuator 804, and the second end 814b of sleeve pipe or the collar 802 can be to be positioned to adjacent second Divide the adjacent part of 810b.Additionally, in the embodiment shown in Figure 58 A-58C, sleeve pipe or the collar 802 and actuator 804 are located at In the distal region of nail 800.However, sleeve pipe or the collar 802 can be positioned on together with actuator 804 along nail 800 various its Its position.

Sleeve pipe or the collar 802 can be shape memory ring, such as shape-memory polymer or metal alloy, its energized with Shrink when being activated, such as when being heated to above body temperature, with adapt to fixing translation or, sleeve pipe or collar 802 are permissible Constructed by piezoelectric, this piezoelectric when being activated to active state from inactive state, to increased or decrease the side of size Formula deforms therefore in response to the outside voltage applying, when sleeve pipe or the collar 802 are adjusted to be in activity or inactive state When, sleeve pipe or the collar 802 can be automatically to activate nail 800 offer locking mechanisms.Therefore, sleeve pipe or the collar 802 can have One size, such as when the length for the moment of the activity that is in or inactive state（As shown in " L " in Figure 58 A）, it is more than the collar Or the second size of sleeve pipe 802 is when the collar or sleeve pipe 802 are in another in activity or inactive state.Additionally, sleeve pipe Or the total length of the collar 802 and actuator 804 assembly or combination can be with somewhat constant, but regardless of sleeve pipe or the collar 802 are in Inactive state or active state.When sleeve pipe or the collar 802 are in activity or inactive state, sleeve pipe or the collar 802 This species diversity of size can change actuator 804 and be in compressive state or at least part of uncompressed state.

For example, according to some embodiments, as shown in Figure 58 B, at least contribute to when shape memory sleeve pipe or collar 802 have Actuator 804 is compressed to compressive state first size or length when, actuator 804 can be at its compressive state.On the contrary, such as Shown in Figure 58 C, when sleeve pipe or the collar 802 be actuated such that the shape memory of sleeve pipe or the collar by sleeve pipe or the collar 802 from first When being resized to the second smaller szie, spring actua 804 can extend to shape extension or that part extends from compressive state State, even and thus at least contribute to adapt to temporary transient adjustment in the corresponding length of power nail 800.

In addition, the displacement of actuator 804 and therefore to the first and second parts 810a, the regulation of the relative position of 810b Can be by using adjustable controller 816（Such as pin or screw）To control.Shown in embodiment as shown in Figure 58 A, adjustable Section controller 816 can be received in the hole 817 in Part II 810b, and in the outer wall 808 of Part I 810a In slit 818, slit 818 be dimensioned to receive in the interior zone 812 of Part II 810b.According to such reality Apply example, controller 816 mechanically can be adjusted by surgeon, and may be configured to prevent the bone section fractured in actuator It is opened during 804 motion.In addition, according to some embodiments, controller 816 can be tightened to prevent first and second Part 810a, the relative displacement of 810b.

（5）Using resorbent encapsulant balancing spring can be activated.

With reference to Figure 59, according to some embodiments, power intramedullary nail 900 can include one or more biasing element 902a, 902b, such as spring, it is each encapsulated in can be in re-absorption housing 904.The pupil of balancing spring is that the bone of shielding fracture is exempted from It is subject to may interfere with the excessive of agglutination and impulsive force.Additionally, the biased element 902a of encapsulation, 902b and intermediary element 906 In the slit 906 that can be sized to be positioned in nail 900.This slit may be located at the near-end of nail, jackshaft or distal area Domain.Can prevent biasing element 902a, the activation of 902b by re-absorption housing 904.In this case, biased element 902a, 902b can via can re-absorption housing 904 power that applies against intermediary element 906, be for example positioned at can re-absorption housing 904 it Between screw a part.As can re-absorption housing 904 associated biasing element 902a, 902b is at moving type State, wherein biasing element 902a, 902b direction and/or direction part can re-absorption housing 904 extend, or expand completely or lax State, and wherein biased element 902a, 902b can be merely provided for the support in pressure fissure gap.This biased element The use of 902a, 902b is conducive to making nail 900 self-regulation and control, and shields fracture from the mistake that may interfere with agglutination Degree and impulsive force.

（C）Before-after（A / P）With inner side-outside（M / L）Stiffness variable nail in plane：A/P and M/ In L plane independent control bending or torsional rigidity ability can allow intramedullary nail be structured with obtain optimal union or Reduce the incidence of Periprosthetic fracture.If patient accepts joint replacement, the local of the bending stiffness of the far-end of nail reduces The risk of prosthese fracture can be prevented.The cross section shown in project B-H in Figure 60 provides the cross section geometric form of intramedullary nail The example of shape, bending stiffness can be reduced about 20% in A/P plane by it, relatively keep in orthogonal M/L plane simultaneously Rigidity.Equally, this cross-sectional geometry can only be suitable to increment manufacture.Additionally, with Figure 60 in project A shown in circle Cross section is compared, and the various cross sections shown in project B-H in Figure 60 can provide following the moment of inertia to subtract in A/P plane Little：Project B is 11% project C is 17-28%；Project D is 7%；Project E is 8%；Project F is 14%；Project G is 7%；? Mesh H is 10%.

Figure 61 A and 61B provides based on 10 millimeters of Trigen tibia nails of standard and 10 millimeters of Trigen Meta tibia nails Reverse and bending stiffness data, it has various sizes of slit on the outer surface of nail.Additionally, Figure 61 A and 61B shows horizontal stroke The sensitiveness to mechanical performance for the cross-sectional geometry.As illustrated, with standard nail compared with, outside nail in A/P plane on Including narrow（1.5 millimeter）, wide（3 millimeters）Or step trough（1.5-3 millimeter）Reduce torsional rigidity to be less than from 3.5Nm/spend 1Nm/degree.Similarly, bending stiffness is also from 23Nm²Decrease below 20Nm².Although the data shown in Figure 61 A and 61B is related to wrap Include the slit positioned at nail outside, but data generally highlights the principle adjusting the nail rigidity in specific anatomical plane.

（D）The internal geometry of relatively low stiffness implant is provided for larger patient：Filled relatively with relatively low stiffness implant The ability of the intermedullary canal of large scale patient can help to accelerate the healing of fracture, particularly when bone is pathologic.In order to keep away Exempt from the geometric properties with exterior design（Such as bone growth）Related any complication, has been summarized below and has utilized increasing material manufacturing Design freedom many designs.

Figure 62 shows the cross-sectional view of intramedullary nail 1000, and it has between the distally and proximally screw hole of nail 1000 The mid portion 1004 of nail 1000 at conical inboard wall 1002. according to some embodiments, taper pars intermedia 1002 can be swallow Tail shape.This taper configurations on the inner surface 1006 of the intubation of nail 1000 can have significant impact to torsional rigidity, If this design feature is intersected with fracture site, this is likely to be of wholesome effect.Additionally, such nail 1000 can allow in bone Quick absorption load during the commitment of folding healing, and do not damage the fatigue behaviour of nail 1000.

Figure 63 provides the mid portion 1004 that identification has the intramedullary nail 1000 of conical inboard wall 1002 and external diameter 1008 （" customization wall thickness "）In theoretical bending and torsional rigidity form.For comparison purposes, Trigen Meta tibia nail （" standard "）It is also included within the table of Figure 63.For the conical inboard wall 1002 having for three external diameter 1008 sizes identifying The theoretical bending of intramedullary nail 1000 is 10 millimeters with the reduction of torsional rigidity, i.e. outer dia（mm）, 11.5 millimeters and 13 millimeters, It is assumed that constant wall thickness is 1.5 millimeters, respectively 17%, 27% and 21.3%.Equipped with customization in mid portion 1004 10 millimeters of conical inboard wall 1002（mm）The theoretical bending rigidity of external diameter nail 1000 is calculated as 42.5Nm².This of nail 1000 is fixed Part processed has and the following bending stiffness comparing：There is the general tibia nail of solid type face AO of 9 mm outer diameter（Synthes）, It is confirmed as 40Nm²；Unslotted profile is followed closely.B ＆ K follows closely, and it is confirmed as 45Nm²；And the fluting wheel that wall thickness is 1.2 millimeters Wide nail.K ＆ S follows closely, and it is confirmed as 40Nm².Also as shown in Figure 63, in torsion, in 1004,1.5 millimeters of mid portion（mm） The theoretical torsional rigidity in wall thickness and 10 mm outer diameter with the customization nail 1000 of conical inboard wall 1002 is 29.8Nm²/2.This is hard Spend and 9.0 millimeters（mm）External diameter Taylor's Russell crowsfeet（22.5Nm²）With 8.5 millimeters（mm）External diameter Trigen Met tibia nail （18.4Nm²）Quite.

Fig. 7 A-7D, 64A-66 and 69 provide the additional implant design providing the rigidity reducing for larger patient.This Design can include the recess into or through nail wall.For example, Figure 64 A shows the one of the mid portion 1102 of intramedullary nail 1000 Partial sectional view, and Figure 64 B shows part thereof of sectional view, and this intramedullary nail 1000 is joined in its inner wall section 1106 Have inner groovy 1104 circumferentially.Groove 1104 can be positioned at distally screw hole 1108a and proximal screws hole 1108b it Between the mid portion 1102 of nail 1100 in.The theoretical bending rigidity of nail 1100 can be reduced including groove 1104.For example, have There is standard 10 mm outer diameter of circular cross sectional shape, the nail of 4.8 millimeters of internal diameters can have 51.2Nm²Bending stiffness. However, groove 1104 is included to this nail bending stiffness being reduced to 48.5Nm².

With reference to Fig. 7 B, Figure 65 and Figure 66, according to other embodiment, intramedullary nail 1200 can include the wall 1204 in nail 1200 A series of open channel 1202. walls 1204 circumferentially inside extending through the wall 1204 of nail 120 can include inner wall part Divide 1203, it generally defines hollow interior region 1205. passage 1202 of nail 1200 can be along the centre of intramedullary nail 1200 Part 1206 extends, such as extend additionally, passage 1202 can in distally and proximally screw hole 1208a, the region between 1208b Can also be arranged along one or more diameters with central longitudinal axis 1210. passage 1202 being roughly parallel to nail 1200. For example, as shown in Figure 66, according to some embodiments, at least a portion of passage 1202 can be arranged around first external diameter 1212a, and Other passages are around the second less internal diameter 1212b arrangement.Passage 1202 can also have various different shape and size, example As cylindrically shaped.Although above-mentioned example is discussed according to the mid portion 1206 of nail, the passage being discussed 1202 structures can also be used together with the other parts of implant, to guarantee that fracture site can be with the nail of low modulus part 1200.

According to exemplary embodiment, the nail 1200 shown in Figure 65 and 66 may include passage 1202 circumferentially, its tool There is the circular cross sectional shape of about 1 mm dia.In the nail with 13 mm outer diameter and 4.8 mm dia inner wall section 1200 The wall 1204 of son 1200 includes such passage 1202 and can reduce the material in wall 1204（Such as titanium）Volume fraction from 100% to 76%, the volume fraction in the space in the wall 1204 being provided by passage 1202 is 24%, thus producing relatively low hole Rate structure.Shown in table as shown in Figure 66, in this case, the theoretical bending stiffness of nail 1200 and torsional rigidity are permissible Respectively from 156.9N.m²/119.2Nm²It is reduced to 110.1/83.4Nm².

Figure 68 provides the elastic modelling quantity that can be used for the porosity needed for elastic modelling quantity estimating coupling cortical bone to density Figure.As illustrated, atresia titanium -64, elastic modelling quantity respectively 114 gigapascals of 316 stainless steels and cobalt chromium（GPa）, 193GPa And 235GPa.Additionally, bone, Ti-64 and 316 stainless density can be respectively 2.4g/cm 3,4.7g/cm 3 and 8.8g / cm 3.Using composite mixture rule, by the porosity of titanium -64 alloy from 0 increase to 40% by elastic modelling quantity from 114GPa is reduced to 68.4GPa, and this is closer to the upper limit of cortex bone（40GPa）.Therefore, porous titanium implant can help reduce Implant（Such as intramedullary nail）Rigidity mismatch and bone tissue between, thus reduce stress shielding.However, increasing porosity and hole Footpath may result in the reduction of implant mechanical performance.Therefore, the balance between mechanical performance and biology performance can be for difference Implant application and change.

With reference to Figure 69, according to another embodiment, the elastic modelling quantity of intramedullary nail 1300 can also be by outer in nail 1300 Accommodate detachable interior section 1302 at least a portion of portion's part 1304 to adjust.Interior section 1302 can be fixing The inner surface 1306 of the intramedullary nail 1300 at one of the near-end 1308a and far-end 1308b in nail place, but can be by nail Near-end 1308a or far-end 1308b in another at lock screw（Not shown）As illustrated, interior section 1302 includes There is the wall 1310 of exterior section 1312 and interior section 1314, the interior section 1314 of wall 1310 generally defines interior section 1302 hollow interior region.Exterior section 1312 wall 1310 is sized to adapt to interior section 1302 around nail 1300 The near-end 1308a of the lateral displacement of exterior section 1304 and nail 1300 is at least connected with the far-end 1308b that part is with respect to nail Displacement 1300, or vice versa as the same.

This variable modulus nail 1300 can enable implant assume higher rigidity during union, and this is permissible For at least serious fracture pulverized, wherein during initial healing, need bigger nail hardness and stability.However, intramedullary nail 1300 construction, so that the bone once fractured has healed, reduces the elastic modelling quantity of nail 1300 in minimally invasive mode, and And do not need to remove nail 1300.For example, if another rigid intramedullary nail is removed after knitting, the load on bone can With significant increase, this can lead to fracturing again in the case of having significant patient activity.This situation can include bone Matter osteoporotic fractures, wherein high rigidity follow closely, for example have osteoporotic femur bending stiffness about 300% nail, permissible Reduce bone strength.However, after union, soft is followed closely, such as have in the marrow of Figure 69 of detachable interior section 1302 Nail 1300, it is possible to reduce the effect of stress shielding, and can be than relatively hard nail.For example, Figure 70 shows that offer has 8.5 Millimeter（mm）Bending with the standard Trigen Meta tibia nail of 10mm external diameter and torsional rigidity with similar to shown in Figure 13 The table 69 of the comparison that " customization " of nail 1300 is followed closely, it has 10 millimeters of outer section.Additionally, " customization " nail tool referring in Figure 70 There is the interior section 1302 with wall 1310, this wall 1310 includes the exterior section 1312 with 7.6 mm dias and has The interior section 1314 of 4.8mm diameter.As shown in Figure 70, the torsion of this nail and bending stiffness can be respectively 8.5/ 26.2Nm²With 12.1/37.3Nm².

Although describing above-mentioned implant and method but it is to be understood that implant and side already in connection with shaping medulla externa nail Method be can be used for other technologies field and/or is associated with other kinds of orthopaedic implants.To institute as herein described The various changes and modifications of embodiment of description will be apparent from for those skilled in the art, and can without departing from The spirit and scope of the present invention and carry out in the case of not reducing its expected advantage such changing and changing.Although in addition, Accompanying drawing and description above are illustrated in detail in and have described the present invention, it should be appreciated that it is characteristically explanation Property rather than restricted it will be appreciated that only illustrate and describing selected embodiment, and expect that protection falls into herein Modification in the scope of the present invention that is described or being defined by the following claims.

Claims (60)

1. a kind of method for manufacturing orthopedic appliance, including：

To form the orthopedic part of increasing material manufacturing by medical grade powder and via increasing material manufacturing process；

It is heat-treated the orthopedic part of described increasing material manufacturing；And

The orthopedic part of processing heat-treatment increasing material manufacturing, to form described orthopedic appliance.

2. the method for claim 1 is it is characterised in that the step of described formation includes producing rectifying of described increasing material manufacturing The threedimensional model of shape part.

3. method as claimed in claim 1 or 2 is it is characterised in that the step of described formation includes swashing of at least 300 watts of utilization The direct metal sintering of luminous power, and wherein, described medical grade powder is at least 5 grades of powder.

4. method as claimed in any preceding claim is it is characterised in that described medical grade powder is TiAl6V4 powder.

5. method as claimed in any preceding claim is it is characterised in that the step of described heat treatment is included using at least 1000 DEG C of temperature carries out high temperature insostatic pressing (HIP) to the orthopedic part of described increasing material manufacturing, and with 0.24 DEG C of min-1 and 72 DEG C of min-1 Between the orthopedic part to cool down described increasing material manufacturing for the cooldown rate.

6. method as claimed in any preceding claim it is characterised in that the step of described processing include polishing be heat-treated Increasing material manufacturing orthopedic part.

7. method as claimed in any preceding claim has not rounded it is characterised in that the step of described formation includes formation The orthopedic part of the increasing material manufacturing of cross-sectional profile.

8. method as claimed in any preceding claim is it is characterised in that described orthopedic appliance is intramedullary nail.

9. method as claimed in claim 8 is it is characterised in that described intramedullary nail has between 84 centimetres and 156 centimetres Radius of curvature.

10. the method any one of claim 1,2 and 4-9 it is characterised in that formed as described in increasing material manufacturing rectify The step of shape part includes：

Laser sintered described medical grade powder provides the multiple laser sintered of shape with the orthopedic part being formed as described increasing material manufacturing Layer；And

The plurality of laser sintered layer of refuse.

11. methods as claimed in claim 10 are it is characterised in that the step of described refuse is included along two unilateral directions Double scanning processes.

12. methods as claimed in claim 10 are it is characterised in that the step of described refuse includes alternately hachure laser light Grid and circumferential laser grating, described alternately hachure laser grating includes the scanning process along two unilateral directions.

13. methods any one of claim 1,2 and 4-9 it is characterised in that increasing material manufacturing as described in being formed orthopedic The step of part includes the outer surface of orthopedic part and the inner surface of laser sintered described increasing material manufacturing, laser sintered outer surface Separated with laser sintered inner surface by least multiple unsintered medical grade powder, and wherein, the step of described heat treatment Including the plurality of unsintered medical grade powder of fusing.

14. methods any one of claim 1-4 and 6-13 are it is characterised in that increasing material manufacturing as described in heat treatment The step of orthopedic part includes：

Pressure by the depollution of environment at the orthopedic part place of described increasing material manufacturing to about 15mb；

The temperature of the orthopedic part of described increasing material manufacturing is increased between 920 DEG C and 1000 DEG C；

The pressure of the environment that the orthopedic part of described increasing material manufacturing is located maintains under 98MPa to 108MPa；And

Cool down the temperature of the orthopedic part of described increasing material manufacturing with 10 DEG C/min or the speed less than 10 DEG C/min.

15. methods as claimed in claim 14, also include carrying out stress to the orthopedic part of heat-treatment increasing material manufacturing releasing The step put.

16. methods as described in claims 14 or 15, also include the orthopedic part of heat-treatment increasing material manufacturing is moved back The step of fire.

17. methods as claimed in any preceding claim are it is characterised in that process the orthopedic portion of heat-treatment increasing material manufacturing The step of part includes removing the α shell of the orthopedic part of described increasing material manufacturing using sandblasting.

18. methods as claimed in claim 17 are it is characterised in that the step of described processing is additionally included on described orthopedic appliance The step forming the compression layer of residual stress.

19. methods as claimed in claim 18 it is characterised in that the step of described processing also include orthopedic described in extrusion honing The step of the inner surface of device.

20. methods as claimed in any preceding claim, are additionally included in shape in the inside of orthopedic part of described increasing material manufacturing The step becoming internal sensor probe passage, described internal sensor probe passage does not extend across the outer of described orthopedic appliance Portion.

21. methods as claimed in any preceding claim, also include by heavy metal ion deposit on described orthopedic appliance with The step forming antimicrobial orthopedic appliance.

22. a kind of intramedullary nail, including：

Including the wall of the one or more laser sintered layer of medical grade powder, described wall has outwardly and inwardly, and described inside is substantially Define the interior zone of described intramedullary nail；And

Internal sensor probe passage, it extends at least a portion of described wall, and described internal sensor probe passage is not Extend through the outside of described wall.

23. intramedullary nails as claimed in claim 22 being dimensioned so as to of passage it is characterised in that described internal sensor is popped one's head in Receive the insertion of the sensor probe that screw hole aims in being configured to perform the operation.

At least a portion of 24. intramedullary nails as claimed in claim 23 passage it is characterised in that described internal sensor is popped one's head in It is roughly parallel to and does not extend across the inside of described wall.

25. intramedullary nails as claimed in claim 24 it is characterised in that described internal sensor probe passage not be configured to from The aperture that described intramedullary nail removes unsintered medical grade powder is in fluid communication.

26. intramedullary nails as any one of claim 22-25 are it is characterised in that at least a portion bag of described inside Include conical inboard wall.

27. intramedullary nails as claimed in claim 26 it is characterised in that described conical inboard wall described intramedullary nail distal aperture spiral shell Extend between nail and proximal aperture screw.

A kind of 28. intramedullary nails, including：

It is connected to the first section of the second section by telescopic section, described telescopic section has external diameter, the size of described external diameter It is set in the interior zone being slidably received at least one of described first and second sections, to adapt to described first He The adjustment of the position to axial of the second section, described first and second section structures are for implantation in bone；And

Actuator, it is adapted to provide for bias force so that the location bias to axial of described first and second sections.

29. intramedullary nails as claimed in claim 28 are it is characterised in that described telescopic section is described first section or described The end of two sections.

30. intramedullary nails as claimed in claim 28 are it is characterised in that described telescopic section is located at described first and second Sleeve pipe in the interior zone of both sections, described sleeve pipe is suitable to adapt to both described first and second sections with respect to described set The axial displacement of pipe.

31. intramedullary nails as any one of claim 28-30 are it is characterised in that described intramedullary nail also includes limiting institute State one or more projections of at least displacement to axial of the first section and described second section.

32. intramedullary nails as any one of claim 28-31 are it is characterised in that in described first and second sections One of one or two telescopic section and interior zone include one or more grooves, and one or more of grooves are each From in another being received in one of described first and second sections or the telescopic section and interior zone of two In matching recesses, one or more of grooves and described matching recesses are configured to prevent described first section with respect to described The swing offset of two sections.

33. intramedullary nails as any one of claim 28-32 are it is characterised in that described actuator is non-linear or can The spring of variable Rate.

34. intramedullary nails as any one of claim 28-33 it is characterised in that described actuator be embedded into degradable In polymer, described degradable polymer is suitable to release bioactive agent, described life with the degraded of described degradable polymer Thing activating agent is configured to stimulate the union of described bone and/or prevents the infection in bone.

35. intramedullary nails as claimed in claim 34 are it is characterised in that described degradable polymer is configured to offer power to incite somebody to action Described actuator maintains one of expansion or compressive state, until described degradable polymer is degraded to described actuator Bias force can overcome the degree of the power of described degradable polymer.

36. intramedullary nails as described in claim 34 or 35 are it is characterised in that described degradable polymer is suitable to by outside thing Reason energy source puts on degrades during described degradable polymer at least in part.

37. intramedullary nails as any one of claim 28-32 are it is characterised in that described actuator is resilient bushing.

38. intramedullary nails as any one of claim 28-37, also include around flexible section at least a portion position The collar, the described collar can optionally adjust between first size and less second size, to change described actuator Compressive state.

39. intramedullary nails as claimed in claim 38 are it is characterised in that the described collar is by applying and removing activation energy source The shape-memory material of adjustment between described first and second sizes.

40. intramedullary nails as claimed in claim 39 it is characterised in that described activation energy source is at least one of the following, I.e.：Threshold value body temperature or the electronic voltage of reception.

41. intramedullary nails as any one of claim 28-33 and 37-40 are it is characterised in that described actuator includes determining First spring in the groove in described intramedullary nail for the position and second spring, described first enclosing springs can re-absorption housing first In, described second spring is encapsulated in second can be in re-absorption housing, and described first can inhale re-absorption housing and described second again Receive housing and can apply phase in the intermediary element between re-absorption housing by re-absorption housing and described second positioned at described first Anti- power.

42. intramedullary nails as any one of claim 28-41 are it is characterised in that described first and second is partly respective Including the wall having outwardly and inwardly, and wherein, the wall of at least one of described first and second parts includes extending to In at least a portion of described wall and do not extend across described wall outside internal sensor probe passage.

43. intramedullary nails as any one of claim 28-42 are it is characterised in that described first and second is partly respective One or more laser sintered layer including medical grade powder.

44. intramedullary nails as claimed in claim 43 are it is characterised in that described medical grade powder is at least 5 grades of powder.

45. intramedullary nails as claimed in claim 44 are it is characterised in that described medical grade powder is TiAl6V4 powder.

46. intramedullary nails as claimed in claim 45 place it is characterised in that one or more of laser sintered layer has been heated Reason process.

A kind of 47. intramedullary nails, including：

There is wall outwardly and inwardly, described inside generally defines the interior zone of described intramedullary nail；

First screw hole and the second screw hole, described first and second screw holes extend through at least outside of described wall；And

One or more of described wall between described first and second screw holes projection, one or more of projections are not Extend through the outside of described wall, one or more of projections are configured to selectively change the springform of described intramedullary nail Amount.

48. intramedullary nails as claimed in claim 47 are it is characterised in that one or more of projection includes prolonging from described inside Reach one or more of described wall groove.

49. intramedullary nails as claimed in claim 47 are it is characterised in that one or more of projection is included in described wall The multiple passages extending in portion region, the plurality of passage does not extend across the inside and outside of described wall.

50. intramedullary nails as claimed in claim 49 are it is characterised in that at least some of the plurality of passage has cylinder Construction.

51. intramedullary nails as claimed in claim 50 are it is characterised in that the plurality of passage is roughly parallel to described intramedullary nail Longitudinal axis.

52. intramedullary nails as any one of claim 47-50 are it is characterised in that described wall includes the one of medical grade powder Individual or multiple laser sintered layers.

53. intramedullary nails as claimed in claim 52 are it is characterised in that described medical grade powder is at least 5 grades of powder.

54. intramedullary nails as claimed in claim 53 are it is characterised in that described medical grade powder is TiAl6V4 powder.

55. intramedullary nails as claimed in claim 54 place it is characterised in that one or more of laser sintered layer has been heated Reason process.

A kind of 56. intramedullary nails, including：

There is the first section of wall, described wall generally defines the interior zone of described first section；And

It is connected to the second section of inner segments, being sized to for the inside in described first section of described inner segments Lateral displacement at least a portion in region, described inner segments can be by lock screw optionally from described first section Dismounting, to change the elastic modelling quantity of described intramedullary nail.

57. intramedullary nails as claimed in claim 56 are it is characterised in that described first section, described second section and described interior Portion's section each includes the one or more laser sintered layer of medical grade powder.

58. intramedullary nails as claimed in claim 57 are it is characterised in that described medical grade powder is at least 5 grades of powder.

59. intramedullary nails as claimed in claim 58 are it is characterised in that described medical grade powder is TiAl6V4 powder.

60. intramedullary nails as claimed in claim 59 place it is characterised in that one or more of laser sintered layer has been heated Reason process.